PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION September 1, 2026 PRIMED Medical Products, Inc. Mitra Fard Senior Manager, Regulatory Affairs 200, 2003-91 St. SW Edmonton, AB T6X 0W8 Canada Re: K261811 Trade/Device Name: PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: QSO, FYC Dated: May 20, 2026 Received: June 1, 2026 Dear Mitra Fard: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261811 - Mitra Fard Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K261811 - Mitra Fard Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ALLAN GUAN -S For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261811 | ? | | Please provide the device trade name(s). | | ? | | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | | | | Please provide your Indications for Use below. | | ? | | PRIMED Chemotherapy Drug Tested Gowns are non-sterile, single-use isolation gowns intended to be worn by healthcare personnel to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. In addition, these gowns provide protection against chemotherapy drugs. The listed chemotherapy drugs showed no breakthrough within 480 minutes at a standardized breakthrough rate of 0.1 μg/cm²/minute when tested in accordance with ASTM F739:2020 standard. | | | | Chemotherapy Drug Name Carmustine (BiCNU). 3.3 mg/ml, Cisplatin, 1 mg/ml, Cyclophosphamide (Cytoxan), 20 mg/ml, Dacarbazine, 10 mg/ml, Doxorubicin Hydrochloride, 2 mg/ml, Etoposide (Toposar), 20.0 mg/ml, Fluorouracil, 50 mg/ml, Mitomycin C, 0.5 mg/ml, Paclitaxel (Taxol), 6 mg/ml, Thio-Tepa (THT), 10 mg/ml, Vincristine, 1 mg/ml | | | | Please select the types of uses. | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} PRIMED Chemotherapy Drug Tested Gowns (K261811) 510(K) Summary | Summary Date: | September 1, 2026 | | --- | --- | | Manufacturer | PRIMED Medical Products Inc. | | Address: | 200, 2003-91 St. SW, Edmonton, AB, Canada, T6X 0W8 | | Phone Number | +1.877.877.4633 | | Fax Number | +1.780.497.7670 | | Email | mitra.fard@primed.com | | Contact person: | Mitra Fard | | Common name of the device | Medical gowns with chemotherapy labeling claims – Tested for use with chemotherapy drugs | | Trade or Proprietary Name: | PRIMED Chemotherapy Drug Tested Gowns. | | Model Number | PM4-99450: Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 PM4-99460: Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3 | | Regulation Description | Surgical Apparel | | Review Panel | General Hospital | | Regulation number | 878.4040 | | Device Class: | 2 | | Product Code: | QSO, FYC | | Predicate device(s) | K101468 | | Reference Device | K214108 | # Device Description: PRIMED Chemotherapy Drug Tested Gowns are non-sterile, single-use isolation gowns intended to be worn by healthcare personnel to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. In addition, these gowns were tested for chemotherapy drug permeation in accordance with the ASTM F739:2020 standard. # Indication for Use: PRIMED Chemotherapy Drug Tested Gowns are non-sterile, single-use isolation gowns intended to be worn by healthcare personnel to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. In addition, these gowns provide protection against chemotherapy drugs. The listed chemotherapy drugs showed no breakthrough within 480 minutes at a standardized breakthrough rate of 0.1 µg/cm²/minute when tested in accordance with ASTM F739:2020 standard. Chemotherapy Drug Name Carmustine (BiCNU). 3.3 mg/ml, Cisplatin, 1 mg/ml, Cyclophosphamide (Cytoxan), 20 mg/ml, Dacarbazine, 10 mg/ml, Doxorubicin Hydrochloride, 2 mg/ml, Etoposide (Toposar), 20.0 mg/ml, Fluorouracil, 50 mg/ml, Mitomycin C, 0.5 mg/ml, Paclitaxel (Taxol), 6 mg/ml, Thio-Tepa (THT), 10 mg/ml, Vincristine, 1 mg/ml Page 1 of 7 {5} # PRIMED Chemotherapy Drug Tested Gowns (K261811) # 510(K) Summary Comparison of Technological Characteristics | Elements of Comparison | Proposed device | Reference | Predicate | Comments | | --- | --- | --- | --- | --- | | Trade name | PRIMED Chemotherapy Drug Tested Gowns | Medline Orbis Chemo Surgical Gown | 3M Surgical Basis Disposable Surgical Gown | - | | 510k number | K261811 | K214108 | K101468 | - | | Manufacturer | PRIMED Medical Products Inc. | Medline Industries LP | 3M Company | - | | Regulation number | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | | Classification | 2 | 2 | 2 | Same | | Product code | QSO, FYC | FYA-QSO | FYA | Different^{1} | | Indication for use | PRIMED Chemotherapy Drug Tested Gowns are non-sterile, single-use isolation gowns intended to be worn by healthcare personnel to protect both the patient and the wearer from the transfer of microorganisms, body fluids, and particulate material. In addition, these gowns provide protection against chemotherapy drugs. The listed chemotherapy drugs showed no breakthrough within 480 minutes at a standardized breakthrough rate of 0.1 μg/cm^{2}/minute when tested in accordance with ASTM F739:2020 standard. Chemotherapy Drug Name Carmustine (BiCNU). 3.3 mg/ml, Cisplatin, 1 mg/ml, | The Medline Orbis Chemo Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect operating room personnel from transfer of microorganisms, body fluids, and particulate material. Additionally, the gown is intended to protect healthcare personnel from exposure of chemotherapy drugs during their preparation, handling and administration. Non-sterile gowns are to be sold in bulk to repackage/re-labeller establishment for ethylene oxide (ETO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to users after ETO sterilization validation to ISO 11135-1. The Medline Orbis Chemo Surgical Gown meets the level 3 barrier protection requirements in accordance with ANSI/AAMI Standard PB70:2012, Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities. | 3M Basic Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAMI liquid barrier classification | Different^{2} | Page 2 of 7 {6} # PRIMED Chemotherapy Drug Tested Gowns (K261811) # 510(K) Summary | Elements of Comparison | Proposed device | Reference | Predicate | Comments | | --- | --- | --- | --- | --- | | | Cyclophosphamide (Cytoxan), 20 mg/ml, Dacarbazine, 10 mg/ml, Doxorubicin Hydrochloride, 2 mg/ml, Etoposide (Toposar), 20.0 mg/ml, Fluorouracil, 50 mg/ml, Mitomycin C, 0.5 mg/ml, Paclitaxel (Taxol), 6 mg/ml, Thio-Tepa (THT), 10 mg/ml, Vincristine, 1 mg/ml | The Medline Orbis Chemo Surgical gown has been evaluated for resistance to penetration of various chemotherapy drugs per ASTM F739-12 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under conditions of Continuous Contact. Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etoposide [20 mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 | | | | Single use vs. reusable | Single Use | Single Use | Single Use | Same | | Sterility | Non-sterile | Non-sterile and sterile | Sterile | Different^{3} | | Material composition | Laminated non-woven material | Nonwoven Polypropylene spunbond fabric | Nonwoven SMS | Different^{4} | | Design features | Full back, knit cuff, Hook and Loop neck closure, ultrasonically welded seams | Knit cuff, Hook and Loop Neck Closure, waist Ties, Ultrasonically Sealed seams. | Hook and loop neck closure, Tie waist closure, cuff | Same | | Color | Purple and Blue | Light Blue | Blue | Different^{5} | | Use | Over the counter | Over the counter | Over the counter | Same | | Contact duration | Surface, <24 hours | Surface, <24 hours | Not indicated in the summary | Same | | Performance level per AAMI PB70 | AAMI level 2 (PM4-99450) AAMI Level 3 (PM4-99460) | AAMI level 3 | AAMI Level 2 | Different^{6} | | Evaluation per ASTM F739-12 | Carmustine [3.3 mg/ml] >480, Cisplatin [1.0 mg/ml] >480, Cyclophosphamide [20 mg/ml] >480, Dacarbazine [10 mg/ml] >480, Doxorubicin Hydrochloride [2 mg/ml] > 480, | Carmustine [3.3 mg/ml] >480 Cisplatin [1.0 mg/ml] >480 Cyclophosphamide [20 mg/ml] >480 Cytarabine Hydrochloride [100 mg/ml] >480 Dacarbazine [10 mg/ml] >480 Daunorubicin Hydrochloride [5 mg/ml] >480 Doxorubicin Hydrochloride [2 mg/ml] > 480 Etoposide [20 | N/A | Different^{7} | Page 3 of 7 {7} # PRIMED Chemotherapy Drug Tested Gowns (K261811) # 510(K) Summary | Elements of Comparison | Proposed device | Reference | Predicate | Comments | | --- | --- | --- | --- | --- | | | Etoposide [20 mg/ml] >480, Fluorouracil [50 mg/ml] >480, Mitomycin C [0.5 mg/ml] >480, Paclitaxel [6 mg/ml] >480, Thiotepa [10 mg/ml] >480, Vincristine Sulfate [1 mg/ml] >480, Results showed no standardized breakthrough for up to 480 minutes. | mg/ml] >480 Fluorouracil [50 mg/ml] >480 Ifosfamide [50 mg/ml] > 480 Methotrexate [25 mg/ml] >480 Mitomycin C [0.5 mg/ml] >480 Mitoxantrone [2.0 mg/ml] >480 Paclitaxel [6 mg/ml] >480 Thiotepa [10 mg/ml] >480 Vincristine Sulfate [1 mg/ml] >480 Results showed no standardized breakthrough for up to 480 minutes. | | | | Biocompatibility | Under the conditions of the testing, not cytotoxic, not a sensitizer, not an irritant per ISO 10993-5, ISO 10993-10, ISO 10993-23 | Under the test conditions, the subject device was shown to be noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-5, ISO 10993-10, ISO 10993-23 | Biocompatible | Same | | Flammability | Meet the requirements of Class 1 per 16 CFR 1610 | Meets requirements of Flame Resistant 16 CFR Part 1610 for class 1 | Class 1 | Same | | Shelf life | 2 Years (PM4-99450) 3 Years (PM4-99460) | N/A | N/A | - | Page 4 of 7 {8} # **PRIMED Chemotherapy Drug Tested Gowns (K261811)** # **510(K) Summary** 1,2 Different - The proposed devices are AAMI level 2 and 3, non-sterile, chemotherapy drug tested gowns intended for use in non-surgical healthcare settings and are classified under product code QSO-FYC. The predicate devices are AAMI level 2 surgical gowns classified under product code FYA and the reference device is an AAMI level 3 chemotherapy drug tested surgical gown. Although the intended use environments differ all devices are intended to provide barrier protection against the transfer of microorganisms, body fluids and particulate matter for healthcare personnel. The proposed device has also been evaluated for chemotherapy drug permeation resistance to support the additional chemotherapy claim. The difference between the proposed and predicate/ reference devices relates to the clinical use environment rather than fundamental technology or mechanism of action and does not raise new questions of safety or effectiveness. 2.7 The predicate device does not include a chemotherapy drug protection claim, whereas both the proposed and reference devices have been evaluated for permeation and breakthrough resistance against the claimed chemotherapy drugs in accordance with ASTM F739:2020. The results showed no standardized breakthrough for up to 480 minutes for the listed drugs and the devices are safe and effective for its intended use. 3 Different - The predicate and reference devices are supplied sterile or non-sterile (intended to be sterilized prior to use), whereas the proposed device is provided non-sterile and is intended for use in a non-sterile isolation environment where sterility is not required. The intended use of both the predicate and proposed devices is to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material and both have been evaluated for permeation and breakthrough resistance against various chemotherapy drugs. The fact that the proposed device is provided non-sterile and intended for use in a non-sterile, isolation setting does not adversely affect its safety and performance. 4 Different - The proposed device has undergone biocompatibility, performance and chemotherapy drug resistance testing and has been demonstrated to be safe and effective for its intended use. The difference in raw material type does not raise new questions of safety or effectiveness. 5 Different - The difference in colour does not impact the safety or performance of the device. Testing reports confirm that the proposed gown is safe for its intended use. 6 Different - The proposed device includes both AAMI level 2 and 3 gowns, while the predicate device is an AAMI level 2 gown. Each proposed model has been independently tested and demonstrated to meet the applicable AAMI PB70 performance requirements for its barrier level. The differences in barrier level have been reflected in the labelling and do not raise new question of safety or effectiveness. Page 5 of 7 {9} PRIMED Chemotherapy Drug Tested Gowns (K261811) 510(K) Summary # Overall Performance Conclusions: The PRIMED Chemotherapy Drug Tested gowns have been tested for permeation and breakthrough resistance against various types of chemotherapy drugs in accordance with ASTM F739-2020. In addition, this gown has been tested for barrier protection according to ANSI/AAMI PB70:2022 requirements. The testing results demonstrate that the PRIMED Chemotherapy Drug Tested gowns meet the claimed barrier protection requirements as defined by ANSI/AAMI PB70:2022 and were tested for permeation of the listed chemotherapy drugs. Summary of Non- Clinical Testing: | Test Description | Standard | Acceptance Criteria | Results | | --- | --- | --- | --- | | Impact Penetration | AATCC42 | Level 2: ≤ 1.0 gLevel 3: ≤ 1.0 g | Pass | | Hydrostatic Pressure | AATCC 127 | Level 2: ≥ 20 cmLevel 3: ≥ 50 cm | Pass | | Tensile Strength | ASTM D5034 | ≥30 N | Pass | | Seam Strength | ASTM D1683 | ≥30 N | Pass | | Tear Resistance | ASTM D5587 | ≥10 N | Pass | | Cytotoxicity | ISO 10993-5 | Non-cytotoxic under the test conditions | Pass | | Sensitization | ISO 10993-10 | Non-sensitizing under the test conditions | Pass | | Irritation | ISO 10993-23 | Non-irritating under the test conditions | Pass | | Flammability | 16CFR1610 | Class I | Pass | | Linting | ISO 9073-10 | For information only | Pass | | Permeation of liquids and gases | ASTM F739:2020 | No breakthrough at the standardized breakthrough rate of 0.1 μg/cm2/minute, up to 480 minutes | Pass | Page 6 of 7 {10} **PRIMED Chemotherapy Drug Tested Gowns (K261811)** **510(K) Summary**--- # **Summary of Clinical Testing:** No clinical testing was performed in support of this 510(k). # **Conclusion:** Based on the non-clinical testing performed, it can be concluded that PRIMED Chemotherapy Drug Tested Gowns are as safe, as effective and perform as well as or better than the legally marketed predicate device (K101468, 3M Surgical Basis Disposable Surgical Gown). 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