Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.

K211022 · Central Medicare Sdn Bhd · LZA · Dec 22, 2021 · General Hospital

Device Facts

• Record ID: K211022
• Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.
• Applicant: Central Medicare Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Dec 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results. Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

Device Story

Disposable nitrile examination glove; worn by healthcare providers to prevent cross-contamination between patient and examiner. Device provides barrier protection against biological contaminants, specific chemotherapy drugs, fentanyl citrate, and gastric acid. Input: physical barrier requirement during clinical examination. Output: protective hand covering. Used in clinical settings; operated by healthcare professionals. Benefit: reduces risk of exposure to hazardous substances and infectious agents during patient care. Warning: contraindicated for use with Carmustine and Thiotepa due to low breakthrough times.

Clinical Evidence

Bench testing only. Permeation testing performed per ASTM D6978-05 to determine breakthrough detection times for various chemotherapy drugs, fentanyl citrate, and gastric acid. Results demonstrate breakthrough times >240 minutes for most tested agents, with specific exceptions for Carmustine (12.7 mins) and Thiotepa (35.8 mins).

Technological Characteristics

Material: Nitrile. Form factor: Non-sterile, powder-free examination glove. Testing standards: ASTM D6978-05 for chemotherapy drug and chemical permeation resistance. Connectivity: None. Software: None.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs, fentanyl citrate, and gastric acid, with specific contraindications for 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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 22, 2021

Central Medicare Sdn Bhd Muhammad Rahman Product Assistant Manager PT 2609-2620, Batu 8. Jalan Changkat Jong. Teluk Intan, Perak 36000 Malaysia

Re: K211022

Trade/Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZC, LZA, QDO Dated: November 12, 2021 Received: November 26, 2021

Dear Muhammad Rahman:

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.

Clarence W. Murray III, 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) K211022

#### Device Name

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Castric Acid and Fentanyl Permeation Resistance Claims

#### Indications for Use (Describe)

Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.

Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Arsenic Trioxide 1.0 mg/ml >>240 mins

Azacitidine (Vidaza) 25.0 mg/ml > 240 mins Bendamustine HC1 5.0 mg/ml >>240 mins Bleomycin Sulfate 15.0 mg/ml >>240 mins Busulfan 6.0 mg/ml > 240 mins Carboplatin 10.0 mg/ml > 240 mins Carmustine (BCNU) 3.3 mg/ml 12.7 mins Carfilzomib 2.0 mg/ml > 240 mins Cetuximab 2.0 mg/ml >>240 mins Chloroquine 50.0 mg/ml >>240 mins Cisplatin 1.0 mg/ml > 240 mins Cladribine 1.0 mg/ml >>240 mins Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 mins Cyclosporin A 100.0 mg/ml >> 240 mins Cytarabine 100.0 mg/ml > 240 mins Cytovene (Ganciclovir) 10.0 mg/ml > 240 mins Dacarbazine 10.0 mg/ml > 240 mins Daunorubicin 5.0 mg/ml >>240 mins Decitibine 5.0 mg/ml >>240 mins Docetaxel 10.0 mg/ml >>240 mins Doxorubicin Hydrochloride 2.0 mg/ml >>240 mins Epirubicin (Ellence) 2.0 mg/ml >> 240 mins Etoposide (Toposar) 20.0 mg/ml >>240 mins Fludarabine 25.0 mg/ml >>240 mins Fluorouracil 50.0 mg/ml > 240 mins Fulvestrant 50.0 mg/ml > 240 mins Gemcitabine (Gemzar) 38.0 mg/ml >> 240 mins Idarubicin 1.0 mg/ml > 240 mins Ifosfamide 50.0 mg/ml >>240 mins Irinotecan 20.0 mg/ml >>240 mins Mechlorethamine HCl 1.0 mg/ml > 240 mins Melphalan 5.0 mg/ml >>240 mins Mesna 50.0 mg/ml >240 mins Methotrexate 25.0 mg/ml >>240 mins Mitomycin C 0.5 mg/ml >>240 mins

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Mitoxantrone 2.0 mg/ml > 240 mins Oxaliplatin 2.0 mg/ml > 240 mins Paclitaxel 6.0 mg/ml >>240 mins Paraplatin 10.0 mg/ml >>240 mins Pemetrexed 25.0 mg/ml >>240 mins Pertuzumab 30.0 mg/ml >>240 mins Propofol 10.0 mg/ml > 240 mins Raltitrexed 0.5 mg/ml >>240 mins Retrovir 10.0 mg/ml > 240 mins Rituximab 10.0 mg/ml > 240 mins Temsirolimus 25.0 mg/ml >240 mins Thiotepa 10 mg/ml 35.8 mins Topotecan HCl 1.0 mg/ml > 240 mins Trastuzumab 21.0 mg/ml >240 mins Triclosan 2.0 mg/ml >>240 mins Trisenox (Arsenic Trioxide) 1.0 mg/ml >> 240 mins Velcade (Bortezomib) 1.0 mg/ml > 240 mins Vinblastine 1.0 mg/ml >>240 mins Vincristine Sulfate 1.0 mg/ml > 240 mins Vinorelbine 10.0 mg/ml >>240 mins Zoledronic Acid 0.8 mg/ml > 240 mins

CAUTION: Testing showed an average breakthrough time of 35.8 minutes with Thiotepa and 12.7 minutes with Carmustine.

WARNING: Do not use with Carmustine and Thiotepa.

Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

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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