A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Latex Examination Gloves, Powder Free, Polymer Coated

AI/ML Overview

This is an FDA 510(k) clearance letter for "Latex Examination Gloves, Powder Free, Polymer Coated". This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.

Here's why the requested information cannot be extracted and what the document does provide:

No Acceptance Criteria or Device Performance Table: The document states that the device is "substantially equivalent" to legally marketed predicate devices. It does not provide specific performance metrics (e.g., tensile strength, puncture resistance, barrier integrity) or the acceptance criteria for those metrics. This level of detail would typically be found in the 510(k) submission itself, not the clearance letter.
No Study Details (Sample Size, Data Provenance, Ground Truth, Training Set): As this is a clearance letter and not a study report, it does not describe any specific studies conducted by the manufacturer to demonstrate performance. The "substantial equivalence" determination relies on demonstrating that the new device is as safe and effective as a predicate device already on the market, often through comparison of materials, design, and intended use, and sometimes through performance testing if there are significant differences from the predicate. However, the details of such testing, if performed, are not in this letter.
No Information on Experts, Adjudication, or MRMC Studies: These concepts are typically relevant for AI/ML-based diagnostic devices or complex imaging analysis, where expert interpretation and consensus are crucial for establishing ground truth and evaluating human-AI interaction. This document is for a physical medical device (examination gloves), so these types of studies are not applicable or mentioned.
Standalone Performance: The concept of "standalone performance" (algorithm only) is not relevant to a physical medical device like gloves.

What the document does tell us:

Device Name: Latex Examination Gloves, Powder Free, Polymer Coated
Regulation Number & Product Code: 880.6250, LYY (Patient Examination Gloves)
Regulatory Class: I (lowest risk class, subject to general controls)
Indications For Use: A disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Date of Clearance: June 7, 2002
Type of Clearance: 510(k) Premarket Notification, based on "substantial equivalence" to a predicate device.

To obtain the detailed information requested, one would need to access the original 510(k) submission (K021412), which is usually publicly available through the FDA's databases, although often redacted for proprietary information. That submission would describe the specific tests performed (e.g., physical property testing, biocompatibility, leak testing) and the criteria used to demonstrate that the gloves meet recognized standards and are substantially equivalent to marketed predicate devices.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 7 2002

Ms. Linga Sumarta Arista Latindo Industrial, Limited Private 128 Jalan Kyai Haji Muhammad Mansyur. Jakarta Barat, INDONESIA 11210

Re: K021412

Trade/Device Name: Latex Examination Gloves, Powder Free, Polymer Coated Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 29, 2002 Received: May 3, 2002

Dear Ms. Sumarta:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/1 description: The image shows a black and white symbol that appears to be a stylized design. It features a circle with a triangular shape inside, pointing upwards. The triangle is formed by three lines that converge at a point, and the circle seems to be partially obscured or intersected by the triangle's lines, creating a unique and abstract visual.

ARISTA LATINDO INDUSTRIAL LTD. P.T SLOVE MANUFACTURER

OFFICE : JL, K.H. MOH. MANSYUR 128 JAKARTA 11210 - INDONESIA MAILING ADDRESS : P.O. BOX 4129 JKT 11041 · INDONESIA TELEPHONE : (021) 639-1907 (4 LINES) FAX : (62-21) 669-0428, 874-0979 TELEX : 42004 NIKKO IA

Section No. 3.

ATTACHMENT #2

INDICATIONS FOR USE STATEMENT

Applicant:	PT. ARISTA LATINDO IND. LTD.
510(k) Number (if known):
Device Name:	Latex Examination Gloves, Powder Free, Polymer Coated
Indications For Use:

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Preseription Use Per 21 CFR 801.109 ਾਕ

Over-The-Counter______________________________________________________________________________________________________________________________________________________________

(Optimal Format 1-2-96)

Olim S. hn

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _

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.