USP 800 Compliance

usp 800 compliance products from cleanroom connection

USP 800 Compliance Supplies for Hazardous Drug Handling

USP <800> establishes standards for handling hazardous drugs in healthcare settings to help protect pharmacists, pharmacy technicians, nurses, and other personnel from exposure risks. Facilities that compound, transport, administer, or dispose of hazardous drugs must implement procedures and use appropriate personal protective equipment (PPE) to support compliance.

USP 800 compliance products include chemotherapy gowns, chemotherapy gloves, hazardous drug wipes, cleanroom apparel, and other contamination control supplies designed to reduce occupational exposure. These products play an important role in maintaining safe handling practices throughout the hazardous drug lifecycle.

Cleanroom Connection offers a complete selection of USP 800 compliance supplies for pharmacies, hospitals, oncology centers, and healthcare facilities. Our products help support hazardous drug handling programs while assisting facilities with USP <800>, USP <797>, and regulatory compliance initiatives.

What Is USP 800?

USP <800> is a United States Pharmacopeia standard that establishes requirements for handling hazardous drugs in healthcare environments. The standard addresses employee safety, environmental protection, contamination control, and procedures designed to minimize exposure during compounding, administration, transportation, and disposal.

Facilities handling hazardous drugs are expected to implement engineering controls, work practices, and appropriate personal protective equipment to reduce exposure risks.

USP 800 Product Categories

Product Type Compliance Benefit
Chemotherapy Gowns ASTM-tested hazardous drug protection gowns
Chemotherapy Gloves USP 800-required hand protection
Hazardous Drug Wipes Surface decontamination and cleaning kit specifically for hazardous drug cleanup
Sterile Wipes Cleaning and disinfection support
Chemo-Rated Sterile Apparel Cleanroom suits that have been tested for chemotherapy permeation
Chemo-Rated Shoe Covers Cleanroom shoe covers that have been tested for chemotherapy permeation
Chemo-Rated Sleeve Covers Cleanroom sleeves that are rated for hazardous drug permeation
Chemo Spill & Prep Mats Sterile hazardous drug prep mats that are super absorbent

Common USP 800 Applications

Facility Type Typical Use
Hospital Pharmacies Hazardous drug compounding
Oncology Pharmacies Chemotherapy preparation
Infusion Centers Hazardous drug administration
Specialty Pharmacies HD compounding and handling
Healthcare Systems Hazardous drug storage and transport
Research Facilities Hazardous drug handling protocols

image representing purple nitrile glove halyard marin glove

* PureZero Marin Nitrile Lab Glove

Halyard PureZero Marin purple nitrile gloves are our most popular non-sterile lab glove. These gloves are not for use in ISO5 Class 100 clean rooms since they come boxed, however they are chemo-rated and suitable for use in less strict ISO7-8 clean rooms. Many customers use these purple nitrile gloves as their non-sterile chemo gloves. They come in both 9 inch and 12 inch lengths. There are 500 gloves per case on the 12″ and 1000 gloves per case on the 9″. These are our most poplar non-sterile nitrile chemo-rated lab glove.

    • Non-Sterile
    • Same glove as Kimberly Clark purple nitrile
    • Economical
    • Powder-free
    • Sizes small through XL
    • Choose 9.5″ or 12″ length
    • ASTM D6978-05 chemo tested
    • USP 800 compliant
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bioclean sterile chemotherapy prep mat

BioClean Sterile Chemotherapy Prep Mat

BioClean sterile chemo prep spill mats come in two convenient sizes : 16″x11″ or 16″x22″. These sterile chemotherapy preparation mats are non-shedding and clean-processed making them suitable for use in ISO5 Class 100 critical environments, including inside of a sterile isolation hood. They are highly absorbent, non-linting, and made of 3 layers.

  • Gamma sterilized
  • 16″x22, 100pcs, individually wrapped
  • 16″x11″, 200pcs, individually wrapped
  • Class 100 ISO5 compatible
  • USP 800 compliant
  • Used to absorb spills or splashes
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true care biomedix sterile chemo gown

Biomedix Sterile Chemotherapy Gown

TCBA54ST True Care Biomedix sterile chemo gowns are our most popular USP 800 compliant chemotherapy gowns. These sterile chemo gowns are comfortable, and have been tested by the ASTM F3267-22 method for chemotherapy permeation. There are 50 sterile gowns per case. Choose from sizes small through 3X-large. Taped seams, closed-front, ISO5 cleanliness and bound seams ensure you are fully protected.

  • Sterile
  • Great for all applications, not just USP 800
  • ASTM F3267-22 compliant
  • USP 800 compliant
  • ISO 5 Class 100
  • Small – 3XL
  • Taped seams
  • Closed front & back
  • Individually packed
  • 50pcs per case
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image representing halyard chemo360 non-sterile chemo gown for usp 800 compliance

Chemo360 Chemotherapy Gown

Halyard Chemo360 chemotherapy gowns meet USP 800 guidelines by providing impervious, seamless protection against hazardous drugs, ensuring the safety of operators and the pharmacy environment. There are 100 non-sterile gowns per case, 10 bags of 10. These gowns are extremely low-linting and also protect against blood-borne pathogens, biologics and other harmful liquids.

  • Non-sterile
  • Tested against 53 chemotherapy drugs on fabric and seams
  • Fabric passed ASTM F739-12, ASTM F1670 & F1671
  • Resistance against fluid and bloodbourne pathogen penetration
  • Polyethylene coated spunbound fabric
  • Full back design with tape-tab neck closure
  • Knit Cuffs
  • USP 800 compliant
  • 100 gowns per case, 10 bags of 10
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cti nsgf nitrile sterile cleanroom gloves

CTI NSGF Nitrile Sterile Cleanroom Gloves

CTI NSGF sterile nitrile surgical cleanroom gloves are made from 100% nitrile with no latex proteins. They are 12 inches long and made for use in ISO5 Class 100 environments. They are chemo-rated and come in individually wrapped pair. These are our most popular sterile nitrile cleanroom glove due to the economical price, bisque-textured grip, and surgical style fit which is great for handling small objects.

    • Most requested sterile glove
    • Sizes from 6.0 – 10.0
    • 200 Pairs Per Case
    • Class 100 ISO5
    • Bisque textured finish
    • 12″ length for good wrist coverage
    • Sterile
    • ASTM D6978-05 Chemo Rated
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haylard purezero sterile blue nitrile cleanroom glove

Halyard PUREZERO Blue Nitrile Sterile Cleanroom Glove

PUREZERO HG3 Blue Sterile Nitrile Cleanroom Gloves are designed for critical cleanroom environments such as pharmaceutical and biotechnology cleanroom manufacturing as well as sterile compounding cleanroom applications. These hand-specific gloves are cleaned and processed (washed repeatedly in deionized water) to ensure consistent control of low particles, extractables, and endotoxin levels. They are recommended for use in ISO Class 3 or higher and Grade A/B cleanrooms. The are accelerator-free to eliminate any skin irritation.

    • Sterile
    • Preferred over Kimtech Sterling sterile nitrile glove
    • Great pricing
    • Thinner 3.9 mil thickness
    • Sizes from 6.0 – 10.0
    • 300 Pairs Per Case, 12″ length
    • Class 10-100 ISO3-5
    • Anti-static & Accelerator-free
    • ASTM D6978-05 Chemo-Rated
    • Great for double gloving, blue under white
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haylard purezero sterile nitrile cleanroom glove

Halyard PUREZERO Nitrile Sterile Cleanroom Glove

PUREZERO HG3 White Sterile Nitrile Cleanroom Gloves are designed for critical cleanroom environments such as pharmaceutical and biotechnology cleanroom manufacturing as well as sterile compounding cleanroom applications. These hand-specific gloves are cleaned and processed (washed repeatedly in deionized water) to ensure consistent control of low particles, extractables, and endotoxin levels. They are recommended for use in ISO Class 3 or higher and Grade A/B cleanrooms. The are accelerator-free to eliminate any skin irritation.

    • Sterile
    • Preferred over Kimtech G3 sterile nitrile glove
    • Great pricing
    • 6.3 mil standard thickness
    • Sizes from 6.0 – 10.0
    • 200 Pairs Per Case
    • Class 10-100 ISO3-5
    • Anti-static & accelerator-free
    • 12″ length for good wrist coverage
    • ASTM D6978-05 Chemo-Rated
    • USP 800 compliant
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handpro fortis 500 extended cuff nitrile lab glove

HandPro Fortis 500 Extended Cuff Nitrile Lab Glove

HandPRO Fortis 500 Extended Cuff Powder-Free Nitrile Exam Gloves are created from the latest patented accelerator-free Low Derma nitrile. The nitrile lab gloves are chemotherapy-rated, and fentanyl-rated making them great for hazardous drug handling. The extended 10.5″ cuff also protects more of your forearm. Fortis 500 lab gloves are thicker than typical exam gloves for increased puncture and abrasion resistance, and features an extended cuff for extra wrist and forearm protection in demanding, high-risk environments. These nitrile lab gloves contain no dithiocarbamates,thiurams or mercaptobenzothiazoles (MBT), or thiurams and are manufactured with no sulfur added.

    • Sizes from XS-XXL
    • 100 gloves per box, 10 boxes per case
    • ASTM D6978-05 chemotherapy rated
    • Fentanyl & Xylazine tested
    • Double-donnable, USP 800 compliant
    • NFPA1999 Compliant for high risk environments
    • Accelerator free & powder-free
    • 10.5″ extended cuff length
    • Non-Sterile
    • Anti-static, finger-textured
    • Matte black color
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handpro freestyle 1100 purple nitrile lab glove

HandPro Freestyle 1100 Purple Nitrile Lab Glove

HandPRO FreeStyle1100™ Nitrile Lab Exam Gloves are accelerator free, ensuring low dermatitis potential, and are highly flexible and conform to the hand. They offer superior flexibility and freedom of hand movement. These lab gloves are chemotherapy-rated and USP 800 compliant. They are latex-free, powder-free glove, and have the fewest chemicals in their composition to avoid Type I latex and Type IV chemical allergic reactions. This unique nitrile formulation sheds liquids better for a more secure grip – even in wet environments. These nitrile lab gloves are made with patented Low Derma™ accelerator-free nitrile, and contain no dithiocarbamates,thiurams or mercaptobenzothiazoles (MBT), and are sulfur & thiuram-free.

    • Sizes from XXS-XXL
    • 100 gloves per box, 10 boxes per case
    • ASTM D6978-05 chemotherapy rated
    • Fentanyl & Xylazine tested
    • Double-donnable
    • 510k rated
    • Accelerator free, powder-free
    • 9.5″ extended cuff length
    • Non-Sterile
    • Anti-static, finger-textured
    • Violet blue color
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haylard purezero sterile blue nitrile cleanroom glove

Haylard PUREZERO Blue Nitrile Cleanroom Glove

PUREZERO HG3 Blue Nitrile Cleanroom Gloves are designed for critical cleanroom environments such as pharmaceutical and biotechnology cleanroom manufacturing as well as non-sterile compounding cleanroom applications. These hand-specific gloves are cleaned and processed (washed repeatedly in deionized water) to ensure consistent control of low particles, extractables, and endotoxin levels. They are recommended for use in ISO Class 3 or higher and Grade A/B cleanrooms. The are accelerator-free to eliminate any skin irritation.

    • Non-sterile
    • Light blue color
    • Tacky grip
    • XS to XL sizes
    • 1500 gloves, 6 bags of 250pcs
    • Class 10-100 ISO3-5
    • Anti-static
    • Accelerator-free
    • 12″ length for good wrist coverage
    • ASTM D6978-05 Chemo-Rated
    • USP 800 compliant
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haylard purezero sterile nitrile cleanroom glove

Haylard PUREZERO Nitrile Cleanroom Glove

PUREZERO HG3 White Nitrile Cleanroom Gloves are designed for critical cleanroom environments such as pharmaceutical and biotechnology cleanroom manufacturing as well as non-sterile compounding cleanroom applications. These hand-specific gloves are cleaned and processed (washed repeatedly in deionized water) to ensure consistent control of low particles, extractables, and endotoxin levels. They are recommended for use in ISO Class 3 or higher and Grade A/B cleanrooms. The are accelerator-free to eliminate any skin irritation.

    • Non-sterile
    • XS to XL sizes
    • Tacky grip
    • 1000 gloves, 10 bags of 100
    • Class 10-100 ISO3-5
    • Anti-static
    • Accelerator-free
    • 12″ length for good wrist coverage
    • ASTM D6978-05 Chemo-Rated
    • USP 800 compliant
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chemoglo hd clean wipes hazardous drug cleanup wipe kit

HD Clean Hazardous Drug Wipe

ChemoGLO HD Clean Wipes deactivate, decontaminate, and remove hazardous drugs including chemotherapy. This hazardous drug cleanup kit was developed to address daily removal of hazardous drug surface contamination in preparation and administration areas such as clean rooms, biological safety cabinets (BSC), laminar flow hoods, counters, infusion chairs, and IV poles and pumps.

    • USP 800 compliant
    • Sterile
    • 8″x7″ wipe size
    • Deactivates, decontaminates, removes hazardous drugs
    • Each set of wipes cleans an 8 sq ft area
    • 2-step wipe procedure
    • Ready to use, saturated
    • Sterile
    • 200 2-wipe packs per case
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