Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs

K220545 · Hl Rubber Industries Sdn Bhd · LZC · May 26, 2022 · General Hospital

Device Facts

• Record ID: K220545
• Device Name: Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
• Applicant: Hl Rubber Industries Sdn Bhd
• Product Code: LZC · General Hospital
• Decision Date: May 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder-free 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Device Story

Disposable powder-free nitrile examination gloves; worn by healthcare personnel during patient examinations to provide barrier protection against cross-contamination. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05. Provides protection in clinical settings; users must observe warnings for specific drugs (Carmustine, Thiotepa) with low breakthrough times. Benefits include reduced risk of exposure to patients and clinicians during medical procedures and chemotherapy handling.

Clinical Evidence

Bench testing only. Performance evaluated via ASTM D6978-05 standard practice for permeation of chemotherapy drugs. Breakthrough detection times reported for 13 substances; warnings provided for drugs with low breakthrough times.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free examination glove. Testing: ASTM D6978-05 for chemotherapy drug permeation. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a disposable patient examination glove by healthcare personnel to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs.

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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May 26, 2022

HL Rubber Industries Sdn bhd Noorzaliza Ahmad QA Executive Lot 10, Kawasan Perindustrian Dioh, Kuala Pilah, Negeri Sembilan 72000 Malaysia

Re: K220545

Trade/Device Name: Powder Free Nitrile Examination Gloves, Blue, 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 Dated: March 25, 2022 Received: March 31, 2022

Dear Noorzaliza Ahmad:

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 medical devices and radiation-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, M.D., Ph.D. Acting 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) K220545

#### Device Name

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

#### Indications for Use (Describe)

A powder-free 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

| No. Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|-------------------------------------------|-----------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 23.4 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (Toposar) (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 77.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Fentanyl Citrate Injection 100.0 mcg/ 2ml | >240 |

Please note that the following drugs have extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 23.4 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 77.5 minute. Warning statements has been included.

WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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