(31 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 patient and examiners.
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.
The provided document describes the acceptance criteria and performance of "Private label-Nitrile Examination Gloves Powder Free" (Nitrile Patient Examination Gloves Pre-powdered) manufactured by PT. Berlian Glovindo.
Here's an breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Minimum/Range) | Reported Device Performance (Typical Values) |
|---|---|---|
| Dimensions (Length) | 240 mm (all sizes) | 240 mm |
| Dimensions (Width) | XS: < 80 mm | < 80 mm |
| S: 80±10 mm | 80±10 mm | |
| M: 95±10 mm | 95±10 mm | |
| L: 111±10 mm | 111±10 mm | |
| XL: > 111 mm | > 111 mm | |
| Thickness (Cuff) | 0.10 mm (min.) | 0.10 mm |
| Thickness (Palm) | 0.10 mm (min.) | 0.10 mm |
| Thickness (Finger Tip) | 0.10 mm (min.) | 0.10 mm |
| Tensile Strength (Before aging) | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation (Before aging) | 700 % (min.) | 700 % (min.) |
| Tensile Strength (After aging) | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation (After aging) | 500 % (min.) | 500 % (min.) |
| Pinhole Requirement | Meets FDA pinhole requirement | Meets FDA pinhole requirement |
| ASTM Standard | Meets ASTM D 3578-95 | Meets ASTM D 3578 Standard |
| Labeling Claim | Meets labeling claim | Meets labeling claim |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size used for the performance testing.
- Data Provenance: The testing appears to have been conducted by the manufacturer, PT. Berlian Glovindo, based in Ceram, Indonesia, to certify the gloves meet specific standards. The data is retrospective in the context of the 510(k) submission, meaning the testing was performed prior to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For physical examination gloves, "ground truth" typically refers to objective measurements and adherence to established industry standards (like ASTM D 3578), rather than expert consensus on subjective interpretations.
4. Adjudication method for the test set:
- This information is not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple human readers (e.g., medical image interpretation). For a device like examination gloves, performance is determined by objective measurements against established standards.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, not for physical medical devices like examination gloves. The document pertains to the performance of the gloves themselves, not the performance of human users with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (examination gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.
7. The type of ground truth used:
- The ground truth is based on objective measurements and adherence to established industry standards. Specifically, the document states:
- "We certify that these gloves meet ASTM D 3578 Standard."
- "Meets FDA pinhole requirement."
- "Meets labeling claim."
8. The sample size for the training set:
- Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As mentioned above, there is no training set for this type of device.
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JUL 29 1999
.jp
PT. BERLIAN 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)" SUMMARYK992177 | |
|---|---|
| (1) Name of applicantAddress | : Mr. Tony Jap: PT. Berlian GlovindoJl. Sutomo Ujung No. 96MedanIndonesiaPhone No. 62-61-616944 62-4-92777Fax 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 JapFax No.: 62-61-8459170 |
| Contact person in U.S.A | : Emmy TjoengFax No.: 626-913-1498 |
| (2) Device detailsTrade NameClassification NameProduct Code | : Private lebel-Nirile Examination Gloves Powder Free: Patient Examination Gloves: Nitrile 80 LZA |
| (3) Equivalent device legallymarketed | : Class I Nitrile Examination Gloves 80 LZAPre-powdered meeting ASTM D 3578-95 |
| (4) Intended use | : A patient examination glove is a disposable deviceintended for medical purpose that is worn on the examiner'shand or finger to prevent contamination between andpatient examiners |
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BERLIAN GLOVINDO
JLN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA
Tel : 62-61-616944 Tel : 62-4-92777 Fax :62-61-8459180
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 < mm | 80±10 mm | 95±10 mm | 111±10 mm | >111mm |
| Thickness1. 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 agingat 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 (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) 638-204g or (301) 443-6597 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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1
ILN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA Tel : 62-61-616944 Tel : 62-4-92777 Fax :62-61-8459180
ANNEXURE II
INDICATION FOR USE
Applicant
: Mr. Tony Jap
Device Name
: Nitrile Patient Examination Gloves Pre-powdered
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.
Qais S. Làn
(Division St Division of Dental, Int and General Hospi r 1 Olk) Number
§ 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.