NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE

• K Number: K992177
• Device Name: NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
• Manufacturer: PT. BERLIAN GLOVINDO
• Date Cleared: 1999-07-29 ( 31 days)
• Product Code: LZA
• Regulation Number: 880.6250

Intended 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 examiners.

Device Description

Private lebel-Nirile Examination Gloves Powder Free, Patient Examination Gloves, Nitrile 80 LZA. The document also provides detailed specifications for the gloves including sizes (XS, S, M, L, XL), length, width, and thickness at the cuff, palm, and finger tip. It also lists physical properties before and after aging, including Tensile Strength and Ultimate Elongation.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance data focus solely on the physical properties and regulatory standards for examination gloves, with no mention of AI or ML.

Therapeutic

No.
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, which is a protective barrier function, not a therapeutic action to treat or alleviate a disease or condition.

Diagnostic

No
The device, a patient examination glove, is intended for barrier protection to prevent contamination, not for diagnosing medical conditions. The performance metrics listed are related to material properties and safety, not diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, which is a hardware device, not software. The description focuses on physical properties and performance standards for the glove itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners." This describes a barrier device used externally on the body.
• Device Description: The description details physical properties and specifications of a glove, not a device used to examine specimens from the body.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information about a patient's health. The performance metrics are related to the physical integrity and strength of the glove, not diagnostic accuracy.

IVD devices are specifically designed to perform tests on specimens taken from the human body to diagnose diseases or other conditions. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 examiners.

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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JUL 29 1999

.jp

PT. BERLIAN GLOVINDO

JLN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA Tel : [phone] Tel : [phone] Fax :[phone]

Page Numbers 1 of 2

| "510 (K)" SUMMARY

K992177
(1) Name of applicant
Address	: Mr. Tony Jap
: PT. Berlian Glovindo
Jl. Sutomo Ujung No. 96
Medan
Indonesia
Phone No. 62-61-616944 62-4-92777
Fax No. 62-61-8459180
The contact persons within the firm as well as in U.S.A are given below:
Contact person in firm	: Mr. Tony Jap
Fax No.: 62-61-8459170
Contact person in U.S.A	: Emmy Tjoeng
Fax No.: 626-913-1498
(2) Device details
Trade Name
Classification Name
Product Code	: Private lebel-Nirile Examination Gloves Powder Free
: Patient Examination Gloves
: Nitrile 80 LZA
(3) Equivalent device legally
marketed	: Class I Nitrile Examination Gloves 80 LZA
Pre-powdered meeting ASTM D 3578-95
(4) Intended 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 and
patient examiners

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BERLIAN GLOVINDO

JLN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA

Tel : [phone] Tel : [phone] Fax :[phone]

Page Numbers 2 of 2

• (5) Technological characteristic of the gloves.
  ::::

Sizes	XS	S	M	L	XL
Length	240 mm	240 mm	240 mm	240 mm	240 mm
Width	80 111mm
Thickness

1. Cuff (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
   | 2. Palm (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
   | 3. Finger Tip (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |

• b. Physical Properties

| | Before aging | After aging
at 100°C 22 hrs. |
|---------------------|---------------|---------------------------------|
| Tensile Strength | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation | 700 % (min.) | 500 % (min.) |

• (6) Performance data is the same as mentioned immediately above.
• (7) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
• (8) Non-clinical data We certify that these gloves meet ASTM D 3578 Standard. Meets FDA pinhole requirement. Meets labeling claim.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1999

Mr. Tony Jap PT. Berlian Glovindo Jln. Raya Medan Rantau Prapat Km +230 Desa Damuli Kec. Labuhan Batu - North Sumatra INDONESIA

Re: K992177 Nitrile Examination Gloves - Pre-Powdered, Trade Name: Small, Medium, and Large Requlatory Class: I Product Code: LZA June 25, 1999 Dated: Received: June 28, 1999

Dear Mr. Jap:

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 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, Druq, 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, 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 (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. ರ್ಗ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Jap

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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) 638-204g or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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ILN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA Tel : [phone] Tel : [phone] Fax :[phone]

ANNEXURE II

INDICATION FOR USE

Applicant

: Mr. Tony Jap

Device Name

: Nitrile Patient Examination Gloves Pre-powdered

Indication for use

K992177

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 examiners.

Qais S. Làn

(Division St Division of Dental, Int and General Hospi r 1 Olk) Number