(51 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.
Latex Examination Gloves - Powder Free
This document is a 510(k) summary for "Latex Examination Gloves - Powder Free" manufactured by PT. Tata Rubberindo Industries. It details the device's characteristics and its conformance to established standards.
Here's an analysis of the provided text to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Latex Examination Gloves - Powder Free" are primarily based on ASTM D 3578-95 Standard specifications for patient examination gloves and FDA pinhole requirements.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Dimensions: | |
| Length (XS, S, M, L, XL) | 240 mm (for 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) | ≥ 21 MPa |
| Tensile Strength (After aging at 70°C 168 hrs) | ≥ 16 MPa |
| Ultimate Elongation (Before aging) | ≥ 700 % |
| Ultimate Elongation (After aging at 70°C 168 hrs) | ≥ 600 % |
| Pinhole Requirement | Meets FDA pinhole requirement |
| Labeling Claims | Meets labeling claims |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for testing the device's performance against the ASTM D 3578-95 standard or the FDA pinhole requirement. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that PT. Tata Rubberindo Industries is based in Indonesia, it can be inferred that testing was conducted either internally, by contract labs, or by a combination of both, potentially in Indonesia or another country specified by the standard. The testing for the 510(k) submission would typically be prospective, as it's for pre-market clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device (patient examination gloves). The "ground truth" for the performance of gloves is established through objective physical and chemical testing against recognized consensus standards (like ASTM D 3578-95) rather than expert consensus on subjective observations. No medical experts or radiologists are involved in establishing the "ground truth" for these physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretations or ambiguous cases require resolution by multiple experts. For physical and chemical testing of gloves, objective measurements are taken, and results are compared directly to the specified thresholds in the standard.
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 information is not applicable. MRMC studies are used for evaluating the effectiveness of diagnostic devices, especially those involving human interpretation (e.g., radiology AI). This device is a physical barrier (glove), not a diagnostic tool, and does not involve human "readers" or AI assistance in its function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. A "standalone" performance study refers to the evaluation of an algorithm's performance without human interaction, typical for AI/software as a medical device. This device is a physical product and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective measurements and laboratory testing conforming to:
- ASTM D 3578-95 Standard Specification for Rubber Examination Gloves: This standard defines the acceptable ranges for physical dimensions (length, width, thickness) and physical properties (tensile strength, ultimate elongation before and after aging).
- FDA Pinhole Requirement: This refers to the leak resistance of the gloves, ensuring they provide an effective barrier.
8. The sample size for the training set
This information is not applicable. This device is a manufactured product, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of device. The "ground truth" (i.e., the performance requirements) refers to the established industry and regulatory standards mentioned in point 7.
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Image /page/0/Picture/1 description: The image shows a logo with the word "TATA" at the bottom. Above the word "TATA" is a symbol that appears to be a person standing with their arms outstretched. Above the person is a semi-circular design with lines radiating upwards, resembling the sun. The logo is black and white.
PT. TATA RUBBERINDO INDUSTRIES
11 th. Floor WISMA ARGO MANUNGGAI
11 th. Floor WISMA Key, 22 11 th. Floor WiSambroto Kav. 22 Jakarta - 12930
Factory : Jl. Raya Serang Km. 13.8 . Jl. Raya Select (Hunling) Phone ( 021 ) 5962436
( 021 ) 5962436
Cikupa - Tangerang : Fax.
Page Numbers 1 of 2
"510 (K)" SUMMARY (K991158)
| (1) Name of applicantAddress | : Mr. Andy Tanaka: PT. Tata Rubberindo IndustriesJl. Raya Serang Km. 13.8Cikupa - TangerangJakarta - IndonesiaPhone No. 62-21-5962435Fax No. 62-21-5962436 |
|---|---|
| The contact persons within the firm as well as in U.S.A are given below: | |
| Contact person in firm | : Mr. Andy TanakaFax No. 62-21-5962436 |
| Contact person in U.S.A | : Cindy TungFax No. : 626-913-1498 |
| (2) Device detailsTrade NameClassification NameProduct Code | : Latex Examination Gloves - Powder Free: Patient Examination Gloves: Latex 80 LYY |
| (3) Equivalent device legallymarketed | : Class I Latex Examination Gloves 80 LYYPowder - Free meeting ASTM D 3578-95 |
| (4) Intended use | : A patient examination glove is a disposabledevice intended for medical purpose that is worn onthe examiner's hand or finger to preventcontamination between and patient examiners. |
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(5) Technological characteristic of the gloves.
| a. DimensionsSizes | 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 |
- Thickness
| ﮨﮯ ﺍﻭﺭ ﺍﯾﺮﺍﻥ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ1. Cuff (min) | 0.10 mm 0.10 mm 0.10 mm | ||
|---|---|---|---|
| 2. Palm (min) | |||
| 3. Finger Tip (min) 0.10 mm 0.10 mm 0.10 mm 0.10 mm 0.10 mm |
- b. Physical Properties
| Tensile Strength: | Before aging | After agingat 70°C 168 hrs. |
|---|---|---|
| 21 Mpa | 16 Mpa | |
| Ultimate Elongation: | 700 % (min.) | 600 % (min.) |
:
1000
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(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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with healthcare, featuring a staff with a snake winding around it.
TUL I a 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PT. Tata Rubberindo Industries C/O Mr. Andy Tanaka Jl. Raya Serang Km. 13.8 Cikupa - Tangerang INDONESIA
K991158 Re: Latex Examination Gloves - Powder Free Trade Name: Regulatory Class: I Product Code: LYY May 12, 1999 Dated: Received. My 14, 1999
Dear Mr. Tanaka:
This letter corrects our substantially equivalent letter of May 28, 1999 regarding the address.
We have reviewed your Section 510(k) notification of intent to
r have and the bling bline for your device on our labeling We have reviewed your Section 510\/ hockrice on our labeling
market the device ific advice for your device on our labeling market the device fric advice tor goals and additionally 809.10 for in
regulation (21 CFR Part) plance contact the Office of regulation (21 crk rare over anase contact the Office of vitro diagnostic devices), please concase concasso de compliance on Compliance at (301) 394-4692. And one devices that have been
che promotion and advertising of your and the Pedera. the promotion and advertising of your actives of the Pederal
reclassified in accordance with the provisions of the Pederal reclassified in accordance with one from may, therefore, Food, Drug, and Cosmetic Acc (no, a meral controls provisions
market the device, subject to the general controls provisions of the Act The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of include requirements furing practice, labeling, and nevices, good manufacturers misbranding and adulteration.
If your device is classified (see above) into either class II If your device Is classifica (bee assocrited Approval) it may be (Special controls) additional controls. Existing major subject to such addrerenar device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ rederal Regulations, freis as mination assumes compliance with Substancially equivalent active requirements, as set forth in the Good Manufacturing lation (QS) for Medical Devices: Che Quality Oyacem Rogara21 ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . periodic QS inspections, FDA will verify such assumptions.
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Page 2 - Mr. Tanaka
Failure to comply with the GMP regulation may result in railure to comply ... In addition, the Food and Drug regulatory accion. In augublish further announcements concerning your device in the Federal Register. Please note: concerning your device in entere in submission does chis response to your promosou might have under sections 531 not arrect any obrigation your ces under the Electronic through 542 of the net 101 acrises or other Federal laws or regulations .
This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA as described in your 510 (i) please of your device to a legally Finding of Subbeancear oquires in a classification for your marketed predicate active 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 809.10 for in vitro diagnostic devices), please contact the Office of onting draghosere devisor) - Establionally, for questions on Compriance at (301) yertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 2018 11:56 obcainca toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsmamain.html".
Sincerely,
Timothy A. Ulatowski
Timot Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PT TATA RUBBERINDO INDUSTRIES
Floor WISMA ARGO MANUNGGAL Ji. Jend. Gatot Subroto Kav. 22 Jakarta - 12930
02115962436 kupa - Tange
ANNEXURE II
INDICATION FOR USE
: Mr. Andy Tanaka Applicant : Latex Patient Examination Gloves Powder Free Device Name Indication for use :
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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)
Qlim S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 5 : O(k) Number
Prescription Use (Pcc 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Forms: 1-2-96)
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§ 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.