(58 days)
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.
Private lebel-Nirile Examination Gloves Powder Free Blue and White Color : Patient Examination Gloves
The provided text describes the acceptance criteria and performance data for "Nitrile Examination Gloves Powder Free Blue and White Color" manufactured by PT. Berlian Glovindo.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirement) | Reported Device Performance (Test Results as per ASTM D 3578-95) |
|---|---|
| Dimensions: | |
| Length (XS, S, M, L, XL) | 240 mm (all sizes) |
| Width (XS) | < 80 mm |
| Width (S) | 80 ± 10 mm |
| Width (M) | 95 ± 10 mm |
| Width (L) | 111 ± 10 mm |
| Width (XL) | > 111 mm |
| Thickness: | |
| Cuff (min) | 0.10 mm |
| Palm (min) | 0.10 mm |
| Finger Tip (min) | 0.10 mm |
| Physical Properties: | |
| Tensile Strength (Before Aging) | 14 Mpa (min.) |
| Tensile Strength (After Aging at 100ºC 22 hrs.) | 14 Mpa (min.) |
| Ultimate Elongation (Before Aging) | 700 % (min.) |
| Ultimate Elongation (After Aging at 100ºC 22 hrs.) | 500 % (min.) |
| Characteristic Related Defects Inspection (AQL Level): | |
| Visible defects (Stains, Lumps, Holes etc.) | S-4, 2.5 |
| Watertight Holes | S-4, 2.5 |
| Dimensions | S-2 |
| Physical Properties (Before and after aging) | S-2 |
| Other: | |
| Weight of residual powder in medium size gloves | 0.5 ± 0.2 mg |
| Bio-Compatibility | Meets FDA pin hole requirement. Meets labeling claim. |
The document states, "(6) Performance data is the same as mentioned immediately above," which indicates that the device met all the listed acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to ASTM D 3578-95 standards for testing. This is a standard specification for rubber examination gloves. While it specifies sampling methods and acceptable quality levels (AQLs) for inspection (e.g., S-4, 2.5 for visible defects and watertight holes; S-2 for dimensions and physical properties), it does not explicitly state the exact sample size used for the specific tests conducted by PT. Berlian Glovindo in this document. The sample sizes would have been determined by the application of the ASTM D 3578-95 standard and the specified AQL levels during the manufacturing and quality control process.
Data Provenance:
- Country of Origin: Indonesia (manufacturer: PT. Berlian Glovindo, located in Medan, Indonesia).
- Retrospective or Prospective: The testing described is part of the product's quality control and regulatory submission, implying it's prospective testing done to demonstrate compliance before market release.
3. 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)
The document does not mention the use of experts to establish a "ground truth" in the clinical or interpretative sense. The ground truth for glove performance is established by objective measurements and standardized tests as defined by ASTM D 3578-95. The tests involve physical measurements (dimensions, tensile strength, elongation), visual inspection for defects, and water leak tests. Therefore, the "experts" would be qualified quality control personnel or laboratory technicians trained in performing these specific ASTM tests. The document does not specify their number or qualifications beyond their adherence to the standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is described. The tests are objective measurements and standardized inspections based on the ASTM D 3578-95 standard, rather than subjective assessments requiring adjudication.
5. 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
This question is not applicable. The device is "Nitrile Examination Gloves," a physical medical device, not an AI software or interpretative tool. Therefore, a multi-reader multi-case comparative effectiveness study with AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of these gloves is defined by the objective performance specifications and test methods outlined in ASTM D 3578-95. This includes:
- Physical measurements: Length, width, thickness.
- Material properties: Tensile strength, ultimate elongation (before and after aging).
- Defect criteria: Visible defects, watertight holes, residual powder, bio-compatibility (meeting FDA pinhole requirement).
8. The sample size for the training set
This question is not applicable. The device is a physical medical glove and does not involve AI or machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for a physical medical device.
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JAN 2 8 2000
RLIAN GLOVINDO
JLN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA Tel : 62-61-616944 Tel : 62-4-92777 Fax :62-61-8459180
Page Numbers 1 of 2
"510 (K)" SUMMARY
| (1) Name of applicant | Mr. Tony Jap |
|---|---|
| Address | PT. Berlian GlovindoJl. Sutomo Ujung No. 96MedanIndonesia |
| 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.
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RLIAN GLOVIND
ILN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA
Tel : 62-61-616944 Tel : 62-4-92777 Fax : 62-61-8459180
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 < mm 80±10 mm 95±10 mm 111±10 mm >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
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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 (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 premation 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 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 : 62-61-616944 Tel :62-4-92777 Fax :62-61-8459180
(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
§ 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.