CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES by C.V. ANLIS ABADI INTERNATIONAL

This document is an FDA 510(k) clearance letter for "Chlorinated Powder Free Latex Examination Gloves." This type of document is generally about regulatory approval of a medical device and does not typically contain detailed acceptance criteria or study results in the manner requested. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market, subject to general controls provisions.

Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided:

A table of acceptance criteria and the reported device performance: This document does not contain specific acceptance criteria or detailed performance data for the "Chlorinated Powder Free Latex Examination Gloves." The FDA clearance is based on substantial equivalence, implying the device meets the standards of its predicate without necessarily requiring a report of novel performance data.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or available for this type of device clearance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or available for this type of device clearance.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an examination glove, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an examination glove.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this type of device (examination glove). The "ground truth" for a medical glove typically relates to its material properties, barrier function, and sterility, which are assessed through standardized tests rather than clinical outcomes or expert consensus on interpretations.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, this document is a regulatory approval letter based on substantial equivalence and does not contain the detailed technical or clinical study data requested.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 1999

Mr. Anwar Firman Managing Director C.V. Anlis Abadi International Jalan Sekip Baru, No.23 Medan INDONESIA

K991155 Re : Chlorinated Powder Free Latex Examination Trade Name: Gloves Requlatory Class: I Product Code: LYY Dated: March 30, 1999 Received: April 6, 1999

Dear Mr. Firman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in the enouse, 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಳ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Firman

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely Yours

Timothy A. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Image /page/2/Picture/0 description: The image shows a logo for a company called ANLIS ABADI. Above the company name is a symbol made of squares. Below the company name is the text "C.V. ANLIS ABADI INTERNASIONAL" and "JALAN SEKIP BARU, NO. 23, MEDAN - INDONESIA".

TEL : (62) 61 557758 / 573068 ~ FAX : (62) 61 535333

Attachment H

Indication For Use Statement

510(K) Number (if known) : K99 || 55 Device Name : Chlorinated Powder Free Latex Examination Gloves Indication For Use :

A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

C.V. Anlis Abadi International

Awiay

Aniger A Managing Direc

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use X

(Optimal Format 1-2-96)

Qum Sahm

(Division Sign-O Division of Dental, I 510(k) Numb

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.