This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This glove is tested for use with Dacarbazine (DTIC), Mitomycin C, Methotrexate, Cyclophosphamide (Cytoxan), Mitoxantrone, Doxorubicin Hydrochloride, Ifosfamide (Ifex), 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol), Vincristine Sulfate

Warning: Not Recommended For Use With Carmustine and Thio-Tepa

Device Description

Powder Free Nitrile Examination Glove (Pink, Green, Orange, White). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, specifically Powder Free Nitrile Examination Gloves. The letter states that the device has been found substantially equivalent to legally marketed predicate devices.

However, this type of regulatory document does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

Here's why and what kind of information you would typically need:

Acceptance Criteria & Device Performance: This letter only states "substantial equivalence." It does not list specific performance metrics (e.g., tensile strength, barrier integrity, chemotherapy drug permeation resistance levels) or the results of tests against predefined criteria. Such information would be in the 510(k) submission itself, specifically in the performance data section.
Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all details pertaining to a clinical study or rigorous performance testing study. The 510(k) letter is a regulatory approval, not the study report. For medical gloves, the "study" is usually a series of bench tests (e.g., ASTM standards for physical properties, chemotherapy permeation tests).

To answer your questions, I would need access to the actual 510(k) submission document, particularly the sections detailing the performance data and testing methods.

What I can infer from the provided text is:

Device Name: Powder Free Nitrile Examination Glove (Pink, Green, Orange, White). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs.
Indications for Use: "This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." And "This glove is tested for use with [list of 12 chemotherapy drugs, with warnings against Carmustine and Thio-Tepa]."
Regulatory Status: Class I medical device (21 CFR 880.6250 - Patient Examination Glove).
510(k) Number: K090412

Without the actual testing data from the 510(k) submission, listing acceptance criteria and device performance is not possible from this document.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2009

Mr. Foo Khon Pu Chief Executive Officer GX Corporation SDN BHD Lot 6487-A, Batu 5 34, Semnta, Jalan Kapar Klang Selangor Darul Ehsan MALAYSIA 42100

Re: K090412

Trade/Device Name: Powder Free Nitrile Examination Glove (Pink, Green, Orange, White), This Product Does Not Contain Thiuram, and/or Carbamate and /or Thiazole. Low Dermatitis Potential.

Tested For Use With Chemotherapy Drugs.

Regulation Number: 21 CFR 880,6250

Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: May 12, 2009 Received: May 14, 2009

Dear Mr. 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. 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.

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Page 2- Ms. Mulnick

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Tanner

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K 090412

Powder Free Nitrile Examination Glove (Pink, Green, Orange, White). Device Name: This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs.

Indication For Use:

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Warning: Not Recommended For Use With Carmustine and Thio-Tepa

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR ·

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Shila A. Murphy MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number

Page 1 of

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.