(73 days)
Fowder Free Latex Examination Glove is a device intended for medical use , worn by the Examiner on his hands / fingers to prevent contamination between Patient and Examiner.
Class 1- Patient Examination Gloves(Powder Free) ROL YY that meets all the requrements ASTM D 3578-95.
The provided text outlines the acceptance criteria and performance data for "Powder Free Latex Examination Gloves" manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED. The study presented is a technical performance study demonstrating equivalence to a predicate device and adherence to ASTM and FDA standards for medical examination gloves.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3578 / FDA Requirement) | Reported Device Performance (SARI Value) |
|---|---|---|
| Dimensions | ||
| Length (Ex-S to Ex-L) | 220 mm min (Ex-S, S); 230 mm min (M, L, Ex-L) | 240-245mm (Ex-S, S, M); 245-250mm (L, Ex-L) |
| Width (Ex-S to Ex-L) | 70 +/- 6 mm; 80 +/- 6 mm; 95 +/- 6 mm; 111 +/- 6 mm; 114 +/- 6 mm | 71mm (Ex-S); 82mm (S); 95mm (M); 106mm (L); 110mm (Ex-L) |
| Thickness (Ex-S to Ex-L) | 0.08 mm minimum | 0.11mm (Ex-S); 0.12mm (S, M); 0.10mm (L); 0.11mm (Ex-L) |
| Physical Properties (Before Ageing) | ||
| Tensile Strength | 14 mpa min. | 21-24 mpa |
| Elongation at Break % | 700% min. | 800-850% |
| Physical Properties (After Ageing) | ||
| Tensile Strength | 14 mpa min. | 19-22 mpa |
| Elongation at Break % | 500% min. | 700-800% |
| Performance Requirements (AQL) | ||
| Freedom from Holes | 4 (ASTM D3578) | 1.5 (SARI) |
| Dimensions | 4 (ASTM D3578) | 4 (SARI) |
| Physical Property | 4 (ASTM D3578) | 4 (SARI) |
| Other Properties | ||
| Powder Content | 2 mg/glove max (ASTM Requirement) | 1 +/- 1 mg per glove (also listed as 80 +/- 20, likely a typo or mislabeling in the document with the 1 +/- 1 mg per glove being the most direct statement of performance against 2mg/glove max) |
| Protein Content | Value not fixed (FDA Requirement) | 80 +/- 20 ppm |
| Moisture Content | Value not fixed (FDA Requirement) | 0.4% maximum |
| Biocompatibility | Biologically Compatible (FDA Requirement) | Biologically Compatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the performance tests. However, it indicates adherence to Acceptance Quality Limits (AQL) standards for inspection (S4 for holes, S2 for dimensions and physical properties), which implies a statistically determined sample size would have been used according to industrial quality control practices.
The data provenance is retrospective, as it's presented as part of a 510(k) submission, showcasing the device's characteristics against established standards. The data originates from India (SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED, Tamil Nadu, India).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is not applicable to this study. The "ground truth" for medical examination gloves is established by predefined international standards and regulations (e.g., ASTM D3578, FDA requirements) rather than expert consensus on individual cases. The testing involves objective measurements against these established criteria.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the "truth" is based on objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, where AI assistance might improve reader performance. This document concerns the physical and chemical properties of a medical glove, which does not involve human interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in spirit, a standalone performance evaluation was done. The device (the glove) is evaluated on its own merits against specified criteria without human intervention affecting its inherent performance. The measurements taken for length, width, thickness, tensile strength, elongation, powder content, etc., are all objective assessments of the device itself.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory requirements, specifically:
- ASTM D3578-95: Standard Specification for Latex Examination Gloves.
- FDA Requirements: For general examination gloves, including pinhole requirements and biocompatibility.
8. The Sample Size for the Training Set
This concept is not applicable to the presented documentation. This is not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of traditional AI/ML. The manufacturing process of the gloves would involve quality control and process monitoring, but this doesn't constitute a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the AI/ML context, this question is not applicable. The "ground truth" for the manufacturing process would be the target specifications defined by ASTM D3578 and FDA regulations, guided by manufacturing best practices and quality control.
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SRI ANUSHAM RUBBER INDUSTRIES TEL: 91 4952 PRIVATE LIMITED 100% EXPORT ORIENTED UNIT
ﮨﮯ ﮐﮧ ﺍﯾﺎ ﮐﺎ ﻟﯿﺎﮞ ﮐﮯ ﻟﯿﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﮐﮯ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﮐﮯ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨ
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TLX: 486 209 SIVA IN Tamil Nadu, 5. India.
K9837998
Vadasery, Nagercoil-629001.
JAN 2 1 1999
| ﺮ | ﺎ | C | 1 | t | ||
|---|---|---|---|---|---|---|
| Q | ದ |
ពុក ខេ V រ ន E ប
KUMARS
FAX: 91 4652
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SIAK SUMMARY as required by : 807.92(c) 1.0
APPI. ICANT . ે. - W NAME
, SKI ANUSHAM RUBBER INDUSTRIES (P) LTD PIONEER MANIKANDAN BUILDINGS VADASERRY, NAGERCOIL-629001 TAMIL NADU , 5.INDIA
: + 91 4652 23091 િમનભાયદ
: + 41 4652 328/1 t: UX
: MK. N.PARAMASIVAN CONINCT PERSON MANAGING DIRECTDR
DEVICE TRADE NAME : NIL
- : Patient fixamination Gloves-Powder Free COMMON NAME ર -
- I EGALLY MARKETED DEVICE TO WHICH বে এ CLAIMING EQUIVALENCE : COMPANAY
Class 1- Patient Examination Gloven(Powder Free) 90L YY the requirements of meets all that ASTM D 3578 - 95.
Type 1 - Gloves compounded primarily from Natural Rubber Latex.
DESCRIPTION OF THE DEVICE: S .
Llass 1- Patient Examination Gloves(Powder Free) ROL YY that meets all the requrements ASTM D 3578-95.
INTENDED USE DE THE DEVICE: ત
Lalex Examination Gloves (Powder Free) referred to as medical device are worn on hand and fingers by the examiner as effective barrier between examiner and patient against exposure to micro organism in blood and other body fluids, waste and equivilent.
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Pioneer Menikandan Buildings.
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983998
7 . ហ
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO PREDICATE DEVICE.
| MeasuredbySRITRIES PRIVATE LIMITED | Parameters of LatexSurgeon's Gloves ManufacturedANUSHAM RUBBER INDUS- | ASTM D 3578Requirement forLatex ExaminationGlove-Powder free | |
|---|---|---|---|
| Characteristics Size | Value | Value | Prescribed |
| 1. Length | Ex-SSMLEx-L | 240-245mm240-245mm240-245mm245-250mm245-245mm | 220 mm minimum220 mm minimum230 mm minimum230 mm minimum230 mm minimum |
| 2. Width | Ex-SSMLEx-L | 71mm82mm95mm106mm110mm | 70 +/- 6 mm80 +/- 6 mm95 +/- 6 mm111 +/- 6 mm114 +/- 6 mm |
| 3. Thickness | Ex-GSMLEx-L | 0.11mm0.12mm0.12mm0.10mm0.11mm | 0.08 mm minimum0.08 mm minimum0.08 mm minimum0.08 mm minimum0.08 mm minimum |
PHYSICAL PROPERTICS
| CHARACTERISTICS | BEFORE AGEING | AFTER AGEING | ||
|---|---|---|---|---|
| *SARI VALUE | ASTM D 3578 REQUIREMENT | SARI VALUE | ASTM D 3578 REQUIREMENT | |
| Tensile Strength | 21-24 mpa | 14 mpa min. | 19-22mpa | 14 mpa min |
| Elongation at Break % | 800-850% | 700% min. | 700-800% | 500% min. |
| *SARI - SRI ANUSHAM RUBHER INDUSTRIES PRIVATE LIMITED |
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KUMHAS VA-UA-YC
10
510 k. Submission
Application Page - 55
VU· 16
1877
4. 26
page 3/5
PERFORMANCE REULITHEMENT
| Characteristics | RelatedDefects | LevelfollowedBy | AQLfollowedby SARI | AQL Valueas perASTM D3578 | |
|---|---|---|---|---|---|
| SARI | As perASTMD3578 | ||||
| Freedom tromHoles | Holes | S4 | S4 | 1.5 | 4 |
| Dimensions | WidthLengthThickness | S2 | S2 | 4 | 4 |
| PhysicalProperty | TensileStrengthElongationat Breakbefore &afterageing. | S2 | S2 | 4 | 4 |
POWDER CONTENT:
| といってーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーSARI VALUE | ASTN REDUIREMENT |
|---|---|
| ー・アーーンやー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・80 +1- 20 | 2mq/glove max |
| ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー |
PROTEIN CONTENT;
| SARI VALUE | FDA REQUIREMENT |
|---|---|
| イター・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・80+1-20ppm | Value not fixed |
MO1STURE CONTENT :
| SARI VALUE | tores and commendent commendent ment compression consideration of theFDA REQUIREMENT |
|---|---|
| 0.4%. | Value not fixedャー・ページーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー |
B I D--COMPA FAU IL I T Y
:
| といっても、このことになっても、その他のことになっている。このコーニングのないというということです。 ここで、SARI GLUVEーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー | FDA REQUIREMENT |
|---|---|
| Biologically CompatibleLook - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | Biologically Compatible |
{3}------------------------------------------------
510 k Submission
Application Page - 56
K983998
Page 4/5
| 8.0 PERFORMANCE DATA | |||
|---|---|---|---|
| The Performance Test Data of the Powder Free Examination Gloves manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT LIMITED is given here-under: | |||
| Measured Parameters of Latex Examination Gloves (Powder Free) manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED | |||
| Characteristics | Size | Value | |
| 1. | Length | Ex-S | 240 - 245 mm |
| S | 240 - 245 mm | ||
| M | 240 - 245 mm | ||
| L | 245 - 250 mm | ||
| Ex-L | 245 - 250 mm | ||
| 2. | Width | Ex-S | 71mm |
| S | 82mm | ||
| M | 95mm | ||
| L | 106mm | ||
| Ex-L | 110mm | ||
| 3. | Thickness | Ex-S | 0.11mm |
| S | 0.12mm | ||
| M | 0.12mm | ||
| L | 0.10mm | ||
| Ex-L | 0.11mm |
PHYSICAL PROPERTIES
| CHARACTERISTICS | Before Ageing | After Ageing |
|---|---|---|
| Tensile Strength | 21-24 mpa | 19-22 mpa |
| Elongation at break % | 800-850% | 700- 800% |
:39
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510 k Submission
Application Page - 57
08-08-92
page 5/5
06:19
| INSPECTION LEVEL OF AQL |
|---|
| ------------------------- |
| CHARACTERISTICS | RELATED DEFECTS | LEVEL | AQL |
|---|---|---|---|
| Freedom from holes | Holes | S4 | 1.5 |
| Dimensions | Length, Width & Thickness | S2 | 4 |
| Physical Properties | Tensile StrengthElongation at Break before & after aging | S2 | 4 |
| POWDER CONTENT | 1 +/- 1 mg per glove |
|---|---|
| PROTEIN CONTENT | 80 +/- 20 ppm |
| MOISTURE CONTENT | 0.4% maximum |
| BI(J-COMPATABILITY | Biologically Compatible |
- ਾ ਹ CLINICAL DATA Not Applicable יי
CONCLUSION OF PERFURMANCE UF TEST DATA
The Powder Free Gloves manufactured by SRI ANUSHAM RUHBER INDUSTRIES PRIVATE LIMITED;
-
- Meet or excreed the ASTM DJ578-45 Specifications
-
- Meet FDA Pin Hole Requirements
-
- Meet Labelling Claim as shown in data under S.No.6
ANY UTHER INFORMATION:
Any other information required by FDA in respect of PRODUCT SAFETY AND EFFECTIVENESS shall be provided on demand.
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Image /page/5/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three parallel lines above them, resembling a stylized bird or symbol of flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1999
SRI Anusham Rubber Industries Pvt. Ltd. C/O Mrs. Latha Kumaraswamy P.O. Box 5206 Pleasanton, California 94566 USA
K983998 Re: Powder-Free Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: Lyy Dated: November 4, 1998 Received: November 9, 1998
Dear Mrs. Kumaraswamy:
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, Drug, 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, qood manufacturing practice, labeling, and prohibitions aqainst 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. ರ್ಗ 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 regulatory 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 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.
{6}------------------------------------------------
Page 2 - Mrs. Kumaraswamy
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) 638-2041 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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510(k) Number (if known): K983998
Device Name: Powder Free Latex Examination Gloves
Indications For Use:
..............................................................................................................................................................................
. . .
3.1 INDICATIONS FOR USE
AFFLICANT SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD t 510(K) NO 술술 DEVICE NAME POWDER FREE LATEX EXAMINATION GLOVES 1
INDICATIONS FOR USE:
Fowder Free Latex Examination Glove is a device intended for medical use , worn by the Examiner on his hands / fingers to prevent contamination between Patient and Examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qus-L
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dey 510(k) Number.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.