(102 days)
The surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Class I natural rubber latex surgeon glove, 79 KGO, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3577-91.
The provided document describes the acceptance criteria and performance data for "PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)".
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D 3577-91) | Reported Device Performance (PROFEEL Powder Free Surgical Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on AQL of 1.0 (indicating better performance than required) |
| 2. Length (mm) | ||
| Size 5½ | min 245 | 277 |
| Size 6 | min 265 | 282 |
| Size 6½ | min 265 | 281 |
| Size 7 | min 265 | 299 |
| Size 7½ | min 265 | 298 |
| Size 8 | min 265 | 298 |
| Size 8½ | min 265 | 298 |
| Size 9 | min 265 | 299 |
| 3. Palm width (mm) | ||
| Size 5½ | 70 ± 6 | 72 |
| Size 6 | 76 ± 6 | 78 |
| Size 6½ | 83 ± 6 | 83 |
| Size 7 | 89 ± 6 | 90 |
| Size 7½ | 95 ± 6 | 95 |
| Size 8 | 102 ± 6 | 102 |
| Size 8½ | 108 ± 6 | 108 |
| Size 9 | 114 ± 6 | 114 |
| 4. Thickness (mm) | ||
| Finger | min 0.10 | 0.23 |
| Palm | min 0.10 | 0.20 |
| 5. Physical Properties | ||
| Before Aging: | ||
| Tensile Strength (MPa) | min 24 | 28.19 |
| Ultimate Elongation (%) | min 750 | 827 |
| After Aging: | ||
| Tensile Strength (MPa) | min 18 | 22.23 |
| Ultimate Elongation (%) | min 560 | 898 |
| 6. Powder Content | - (Not specified in ASTM D 3577-91) | below 2 mg / glove |
| 7. Protein Content | - (Not specified in ASTM D 3577-91) | below 50 microgram / gram |
The study concludes that the PROFEEL Powder Free Surgical Gloves exceed the ASTM D 3577-91 requirements, meet FDA pinhole requirements, and meet the protein content labeling claim.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for each individual test. It refers to "Performance data of gloves to ASTM D 3577-91 and FDA 1000 ml watertight test," which are established standards that would define sample sizes for testing. For example, "S-4, AQL 1.5" for the watertight test refers to a sampling plan from an acceptance sampling standard (often MIL-STD-105E or equivalent) which would specify sample sizes based on lot size and AQL.
The data provenance is from Malaysia, as the manufacturer, Wembley Rubber Products (M) Sdn. Bhd., is located in Sepang, Selangor Darul Ehean, Malaysia. The data is non-clinical performance data, likely generated through laboratory testing of the gloves, not from human subject studies. Therefore, it is retrospective in the sense that the tests were performed on manufactured products, rather than prospectively collected clinical outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for the performance of surgical gloves is established by objective measurements against industry standards (ASTM D 3577-91 and FDA watertight test for pinholes), not by expert consensus or interpretation of subjective data. The tests are designed to quantitatively measure physical properties.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on objective, quantitative measurements against predefined standards, not on subjective interpretations 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 is not applicable. This document describes the performance of a physical medical device (surgical gloves), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. There is no algorithm or AI component to this medical device.
7. The Type of Ground Truth Used
The ground truth used is objective quantitative measurements against established industry standards (ASTM D 3577-91 for physical properties, and FDA 1000 ml watertight test for freedom from pinholes). For powder and protein content, specific laboratory tests (e.g., ASTM D5712 for protein content) are used to provide quantitative "ground truth" values.
8. The Sample Size for the Training Set
This is not applicable. This refers to a manufactured physical product. There is no machine learning model involved that would require a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as above; there is no training set for a physical product like surgical gloves.
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Image /page/0/Figure/0 description: The image shows the letters "WRP" in a bold, sans-serif font. The letters are arranged horizontally, with "W" on the left, "R" in the middle, and "P" on the right. The letters are black and are surrounded by a thick black border that forms a rounded rectangle. The background of the image is white.
5972621
WEMBLEY RUBBER PRODUCTS (M) S
' ot 1, Jalan 3, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehean, Malaysia nt 1, Jalan 3, Kawasan Petusanaan Baliuar Baru Baru Sarak Tinggi, 1990- Bopang, 1996-1495 / 1496 Fax: (603) 846-1488 / 1608
OCT 2 4 1997
CONTACT PERSON : MR. Y. W. CHOW
510 (K) SUMMARY
- : PROFEEL POWDER FREE SURGICAL GLOVES 1. Trade Name (PROTEIN CONTENT LABELING) ( 50 MKroqram or
-
- Common Name : Surgeon Gloves .
-
- Classification Name : Surgeon Glove
4. Substantial Equivalence :
Class I natural rubber latex surgeon glove, 79 KGO, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3577-91.
5. Description of device :
Class I natural rubber latex surgeon glove, 79 KGO, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3577-91.
6. Intended use of device :
The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
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Image /page/0/Picture/18 description: The image shows a circular logo with a heart and an inverted triangle inside. The logo is surrounded by text, but the text is not clear enough to read. The logo appears to be a certification mark or a symbol of quality assurance. The image is black and white and has a slightly grainy texture.
Image /page/0/Picture/19 description: The image shows a black and white logo. The logo consists of a black diamond shape with a white border. Above the diamond is a white oval shape with the word "REGISTERED" in black letters. Below the diamond are the letters "MS ISO 9002 : 1994".
Image /page/0/Picture/20 description: The image shows the CE marking, a symbol used to indicate conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The letters 'CE' are prominently displayed, and below the marking, the text 'COUNCIL DIRECTIVE 93/42/EEC' is visible. This directive is related to medical devices, suggesting the product bearing this mark complies with the relevant European regulations for medical devices.
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7. Summary of Performance data :
K972621
Performance data of gloves to ASTM D 3577-91 and FDA 1000 ml watertight test.
| TEST | ASTM D 3577-91 | PROFEEL Powder FreeSurgical Gloves (ProteinContent Labeling) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4,AQL 1.5 | Pass based on AQL of 1.0 |
| 2. Length (mm) | ||
| Size | ||
| 5½ | min 245 | 277 |
| 6 | min 265 | 282 |
| 6½ | min 265 | 281 |
| 7 | min 265 | 299 |
| 7½ | min 265 | 298 |
| 8 | min 265 | 298 |
| 8½ | min 265 | 298 |
| 9 | min 265 | 299 |
| 3. Palm width (mm) | ||
| Size | ||
| 5½ | 70 ± 6 | 72 |
| 6 | 76 ± 6 | 78 |
| 6½ | 83 ± 6 | 83 |
| 7 | 89 ± 6 | 90 |
| 7½ | 95 ± 6 | 95 |
| 8 | 102 ± 6 | 102 |
| 8½ | 108 ± 6 | 108 |
| 9 | 114 ± 6 | 114 |
| 4. Thickness (mm) | ||
| Finger | min 0.10 | 0.23 |
| Palm | min 0.10 | 0.20 |
| 5. Physical Properties | ||
| Before Aging : | ||
| Tensile Strength (MPa) | min 24 | 28.19 |
| Ultimate Elongation (%) | min 750 | 827 |
| After Aging : | ||
| Tensile Strength (MPa) | min 18 | 22.23 |
| Ultimate Elongation (%) | min 560 | 898 |
| 6. Powder Content | - | below 2 mg / glove |
| 7. Protein Content | - | below 50 microgram / gram |
Page 2 Of 3
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8. Substantial equivalence based on assessment of Non-Clinical performance data
The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3577-91.
Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D5712 is below 50 microgram / gram
9. Conclusion
This glove exceed the ASTM D 3577-91 requirements, meet pinhole FDA requirements and below 50 microgram / gram protein content labeling claim.
Date Summary Prepared : June 14, 1997
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Yue Wah Chow Vice President, Quality Assurance/Regulatory Affairs Wembley Rubber Products (M) Sdn. Bhd. OCT 2 4 1997 Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi, Sepang Selangor, Malaysia
Re : K972621 Profeel Powder Free Latex Surgical Gloves Trade Name: (Protein Content Labeling Claim (50 Microgram or Less) Regulatory Class: I Product Code: KGO Dated: October 14, 1997 October 14, 1997 Received:
Dear Mr. Chow:
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, good 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Chow
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 requlations.
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) 594-4618. 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 requlation 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) : _ K 9 7 26 2 |
Device Name : PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) 50 Microgram of Less
】
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Indications For Use :
-
- The surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Concurrence of CDRH, Office of Device Evaluation (ODE)
- The surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
| S. Lim | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972621 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use X |
|---|---|
| --------------------------------------- | --------------------------- |
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).