Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs

K220644 · Yty Industry (Manjung) Sdn Bhd · LZA · Mar 25, 2023 · General Hospital

Device Facts

• Record ID: K220644
• Device Name: Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
• Applicant: Yty Industry (Manjung) Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Mar 25, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Nittile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient. This glove has also been tested for use with Chemotherapy Drugs.

Device Story

Doffy® Nitrile Examination Glove; single-use, non-sterile, powder-free, ambidextrous, textured, beaded cuff. Used by healthcare professionals to prevent cross-contamination between examiner and patient. Provides barrier protection during patient examinations and handling of chemotherapy drugs. Tested for permeation resistance against various chemotherapy agents; specific breakthrough times provided. Not for use with Carmustine or Thiotepa due to low permeation resistance. Device is a physical barrier; no electronic or software components.

Clinical Evidence

Bench testing only. Permeation testing performed for chemotherapy drugs per ASTM standards. Breakthrough detection times reported for 15 chemotherapy agents.

Technological Characteristics

Nitrile material; powder-free; textured surface; beaded cuff; ambidextrous; single-use. Physical barrier device.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free nitrile examination glove worn on the hand or finger to prevent cross-contamination between examiner and patient. Tested for use with specific chemotherapy drugs. Contraindicated for use with Carmustine and Thiotepa.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 25, 2023

YTY Industry (Manjung) Sdn Bhd Punitha Samy Senior Manager (Group DCRA & YTY Industry QA) Lot 1422-1424, Batu 10 Lekir Sitiawan, Perak 32020 Malaysia

Re: K220644

Trade/Device Name: Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: March 20, 2023 Received: March 22, 2023

Dear Punitha Samy:

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 (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 located 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Bifeng Qian -S

Bifeng Oian, MD, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K220644

#### Device Name

Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs

#### Indications for Use (Describe)

A Nittile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient. This glove has also been tested for use with Chemotherapy Drugs.

| Tested Chemotherapy Drug and Concentration | Min Breakthrough Detection Time (minutes) |
|--------------------------------------------|-------------------------------------------|
| Carboplatin, 10 mg/ml | >240 |
| Carmustine, 3.3 mg/ml | 15.0 |
| Cisplatin (BCNU), 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride, 2.0 m/ml | >240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 |
| Fluorouracil, 5.0 mg/ml | >240 |
| Ifosfamide, 50.0 mg/ml | >240 |
| Methotrexate, 25 mg/ml | >240 |
| MitomycinC, 0.5mg/ml | >240 |
| Mitoxantrone, 2 mg/ml | >240 |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 |
| ThioTEPA, 10.0 mg/ml | 30.1 |
| Vincristine Sulfate, 1.0 mg/ml | >240 |

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 15.0 minutes, Thiotepa (10.0 mg/ml): 30.1 minutes WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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