Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs

K182089 · Platinum Glove Industries Sdn. Bhd. · LZA · Jul 30, 2019 · General Hospital

Device Facts

• Record ID: K182089
• Device Name: Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
• Applicant: Platinum Glove Industries Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 30, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.

Device Story

Disposable nitrile examination glove; worn by healthcare professionals to prevent cross-contamination between patient and examiner. Device provides barrier protection during medical examinations and handling of chemotherapy agents. Permeation testing performed for 14 specific chemotherapy drugs to determine breakthrough detection times. Users must avoid use with Carmustine and Thio-Tepa due to low permeation resistance. Product is non-sterile and intended for single use.

Clinical Evidence

No clinical data. Evidence consists of bench testing for chemotherapy drug permeation (breakthrough detection time) for 14 specific agents.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free examination glove. Principle: Physical barrier protection. Connectivity: None. Software: None.

Indications for Use

Indicated for use as a disposable patient examination glove to prevent contamination between patient and examiner. Tested for resistance to specific chemotherapy drugs. Contraindicated for use with Carmustine and Thio-Tepa.

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.

July 30, 2019

Platinum Glove Industries Sdn Bhd % Foo Pu Managing Director Platinum Glove Industries Sdn. Bhd. Lot 6491-A. Batu 5 3/4. Sementa. Jalan Kapar Selangor Darul Ehsan, 42100 My

Re: K182089

Trade/Device Name: Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: June 22, 2018 Received: July 5, 2018

Dear Foo Pu:

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.

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182089

#### Device Name

Powder Free Blue Nitrite Examination Gloves- Tested for Use with Chemotherapy Drugs.

### Indications for Use (Describe)

A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.

Chemotherapy Drug permeation (Break through Detection Time) in Minutes. The following chemicals have been tested with these gloves.

| 1. Carmustine (BCNU)3.3 mg/ml(3,300ppm) | 9.0 min |
|---------------------------------------------------|----------|
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml (20,000ppm) | >240 min |
| 4. Dacarbazine (DTIC)1 0.0 mg/ml (10,000ppm) | >240 min |
| 5. Doxorubicin Hydrochloride 2.0mg/ml (2,000ppm) | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | >240 min |
| 10. Mitomycin C 0.5 mg/ml (500ppm) | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | 16.2min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | >240min |

Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes.

Do not use with Carmustine and Thio-Tepa

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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