BLUE NITRILE EXAMINATION GLOVES - POWDER FREE

• K Number: K994064
• Device Name: BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
• Manufacturer: GLOVE SOURCE, INC.
• Date Cleared: 2000-01-28 ( 58 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 and patient examiners.

Device Description

Private lebel-Nirile Examination Gloves Powder Free Blue and White Color : Patient Examination Gloves

Predicate Devices

LZA

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard examination glove and explicitly states "Not Found" for mentions of AI, DNN, or ML.

Therapeutic

No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.

Diagnostic

No
The device is a patient examination glove, which is used for preventing contamination, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, which is a hardware medical device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device 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." This describes a barrier device used for protection during physical examination.
• IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with or analyze such specimens.
• Device Description: The description "Patient Examination Gloves" further reinforces its function as a protective barrier.
• Lack of IVD Characteristics: The document lacks any mention of:
  • Analyzing biological samples.
  • Detecting or measuring substances in samples.
  • Providing diagnostic information based on sample analysis.
  • Image processing, AI, or machine learning, which are sometimes associated with advanced IVDs.

This device falls under the category of a medical device, specifically a Class I or Class II device depending on the regulatory jurisdiction, but it is not an In Vitro Diagnostic.

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 and patient examiners.

Product codes

LZA

Device Description

• Dimensions:
  • Sizes: S, XS, M, XL
  • Length: 240 mm (all sizes)
  • Width: S: 80 mm, XS: 80±10 mm, M: 95±10 mm, XL: 111±10 mm, >111mm
  • Thickness:
    • Cuff (min): 0.10 mm (all sizes)
    • Palm (min): 0.10 mm (all sizes)
    • Finger Tip (min): 0.10 mm (all sizes)
• Physical Properties:
  • Before aging: Tensile Strength 14 Mpa (min.), Ultimate Elongation 700 % (min.)
  • After aging at 100°C 22 hrs: Tensile Strength 14 Mpa (min.), Ultimate Elongation 500 % (min.)
• Performance Requirement Characteristic Related Defects Inspection AQL Level:
  • Visible defects (Stains, Lumps, Holes etc.): S-4, 2.5
  • Watertight (Holes): S-4, 2.5
  • Dimensions (Width, Length & Thickness): S-2
  • Physical Properties (Before and after ageing): S-2
• Weight of residual powder in medium size gloves: 0.5 ± 0.2 mg
• Bio-Compatibility: Test Results as per ASTM D 3578-95
• Meets FDA pin hole requirement.
• Meets labeling claim.

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

Examiner / 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)

Performance data is the same as mentioned immediately above [in the device description].

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

Not Found

Predicate Device(s)

Class 1 Nitrile Examination Gloves 80 LZA Powder Free meeting ASTM D 3578-95

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

JAN 2 8 2000

RLIAN GLOVINDO

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

Page Numbers 1 of 2

"510 (K)" SUMMARY

K994064

(1) Name of applicant	Mr. Tony Jap
Address	PT. Berlian Glovindo
Jl. Sutomo Ujung No. 96
Medan
Indonesia
Phone No.	62-61-616944 62-4-671077 671088
Fax No.	62-61-8459170

The contact persons within the firm as well as in U.S.A are given below

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
  : Private lebel-Nirile Examination Gloves Powder Free Blue and White Color : Patient Examination Gloves

• Classification Name : Nitrile 80 LZA Product Code

• (3) Equivalent device legally : Class | Nitrile Examination Gloves 80 LZA marketed Powder Free meeting ASTM D 3578-95

• (4) Intended use : patient examination glove is a disposable device A intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between and patient examiners.

1

RLIAN GLOVIND

ILN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA

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

Page Numbers 2 of 2

• Dimensions a. S XS M XL Sizes ﺎ 240 mm 240 mm 240 mm 240 mm 240 mm Length 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 100ºC 22 hrs. Tensile Strength 14 Mpa (min.) 14 Mpa (min.) Ultimate Elongation 700 % (min.) 500 % (min.) Performance Requirement C. Characteristic Related Defects Inspection AQL Level Visible defects Stains, Lumps, S-4 2.5 Holes etc. Watertight Holes S-4 2.5 Dimensions S-2 Width Length 4 & Thickness Physical Properties ട-2 Before and 4 after ageing d. Weight of residual powder in medium size gloves : 0.5 ± 0.2 mg e. Bio - Compatibility g. Test Resulth as per ASTM D 3578 -95 (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-dinical data Gloves meet or exceed the ASTM D 3578 Standard.

(5) Technological characteristic of the gloves,

Meets FDA pin hole requirement.

Meets labeling daim.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above and below them. The profiles are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CIAN 2 8 2000

Emmy Tjoeng Mr. Official Correspondent for PT. Berlian Glaovindo Jln. Sutomo Ujung 96 Medan 20235 - Indonesia

Re : K994064 Trade Name: Nitrile Examination Gloves - Powder Free Requlatory Class: I Product Code: LZA November 30, 1999 Dated: Received: December 1, 1999

Dear Dr. Tjoeng:

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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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. Please note: this response to your premarket notification submission does not affect any

3

Page 2 - Mr. Tjoeng

obligation you might have under sections 531 through 542 of obligation 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 marice 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 regaradiagnostic 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 premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at at Its coll free namber (65)/www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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

(K994064)

ANNEXURE II

INDICATION FOR USE

Applicant	: Mr. Tony Jap
Device Name	: Nitrile Patient Examination Gloves Powder Free
Indication 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qum S. Lin

(Division Sign Off) Division of Dental, Infection Control, and General Hospital Devic 510(K) Number K GU

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use