(228 days)
The surgeon's glove is a device made of synthetic copolymer intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Class I synthetic surgeon's glove, 79 KGO, powdered. It is a styrene-butadiene block copolymer glove.
The provided text describes the acceptance criteria and performance of "PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)" based on a 510(k) submission (K982600) to the FDA. The study aims to demonstrate substantial equivalence to a predicate device by meeting ASTM D3577-91 Type 2 and FDA 1000 ml watertight test requirements.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST | Acceptance Criteria (ASTM D3577-91 Type 2) | Reported Device Performance (PROFEEL Synthetic Copolymer Surgical Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on: 1) Single Sampling Plan, S-4, AQL 1.5 2) Multiple Sampling Plan, GII, AQL 2.5 |
| 2. Length (mm) | ||
| Size 6½ | min 265 | 301 |
| Size 7 | min 265 | 299 |
| Size 7½ | min 265 | 298 |
| Size 8 | min 265 | 301 |
| Size 8½ | min 265 | 303 |
| 3. Palm Width (mm) | ||
| Size 6½ | 83 ± 6 | 85 |
| Size 7 | 89 ± 6 | 92 |
| Size 7½ | 95 ± 6 | 96 |
| Size 8 | 102 ± 6 | 104 |
| Size 8½ | 108 ± 6 | 110 |
| 4. Single Wall Thickness (mm) | ||
| Finger | min 0.10 | 0.27 |
| Palm | min 0.10 | 0.25 |
| Cuff | min 0.10 | 0.20 |
| 5. Physical Properties (Type 2) | ||
| Before Aging: | ||
| Tensile Strength (MPa) | min 17 | 19.62 |
| Ultimate Elongation (%) | min 650 | 1108 |
| Stress at 500% Elongation (MPa) | max 7.0 | 1.92 |
| After Aging: | ||
| Tensile Strength (MPa) | min 12 | 16.35 |
| Ultimate Elongation (%) | min 490 | 1101 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact numerical sample size for each test. However, for the watertight test, it refers to "Single Sampling Plan, S-4, AQL 1.5" and "Multiple Sampling Plan, GII, AQL 2.5." These are statistical sampling plans defined by ISO standards (or equivalent for medical devices) that dictate sample size based on lot size and acceptable quality limits (AQL). Without the lot size, the exact sample numbers cannot be determined from this text alone. For other physical property tests, specific sample sizes are not mentioned.
- Data Provenance: The data originates from "WEMBLEY RUBBER PRODUCTS (M) SDN BHD" located in Sepang, Selangor Darul Ehsan, Malaysia. The data appears to be retrospective as it's presented in a regulatory submission to demonstrate compliance of an already manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (device performance against a standard) does not typically involve human experts establishing a "ground truth" in the same way an AI diagnostic study would. The acceptance criteria themselves (ASTM D3577-91 Type 2 and FDA 1000ml watertight test) serve as the objective 'ground truth' against which the device performance is measured. The tests are typically conducted by trained technicians in a laboratory setting according to the standard's procedures. The document does not mention any experts in this context.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a performance test against objective standards, not a diagnostic task requiring expert adjudication of results. The "adjudication" is whether the measured values meet the specified limits of the ASTM standard and FDA watertight test.
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
Not applicable. This is a study evaluating the physical performance specifications of a medical device (surgical gloves), not a comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm study. It's a physical device performance study.
7. The Type of Ground Truth Used
The ground truth used is objective performance standards defined by:
- ASTM D3577-91 Type 2 (Standard Specification for Rubber Surgical Gloves)
- FDA 1000 ml watertight test requirements
These standards specify the acceptable ranges for various physical and performance characteristics of surgical gloves.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI study, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set. The "ground truth" for evaluating the glove's performance against regulatory requirements is established by the specifications within the ASTM D3577-91 Type 2 standard and the FDA's watertight test criteria.
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3/12/99
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Kg82600
WEMBLEY RUBBER PRODUCTS (M) SDN BHD (No: 147817-V)
Lot 1. Jalan 3. Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia. Tel: +60 3-8461486 (20 Lines) Marketing/QA Fax: +60 3-8461485/1557 Operations Fax: +60 3-8461488
ATTACHMENT 3
CONTACT PERSON : Y. W. CHOW
510(k) SUMMARY
- PROFEEL SYNTHETIC COPOLYMER SURGICAL 1. Trade Name • GLOVES (POWDERED)
- Surgeon's Gloves 2. Common Name :
- Surgeon's Glove 3. Classification Name :
Substantial Equivalence : 4.
Class I synthetic surgeon's glove, 79 KGO, powdered. It is a styrene-butadiene block copolymer glove. The device is identical, and substantially equivalent to the Elastyren Surgical Glove manufactured by ECI Medical Technologies Inc., Canada. It meets all of the requirements of ASTM standard D3577-91 Type 2.
5. Description of Device :
Class I synthetic surgeon's glove, 79 KGO, powdered. It is a styrene-butadiene block copolymer glove. The device is identical, and substantially equivalent to the Elastyren Surgical Glove manufactured by ECI Medical Technologies Inc., Canada. It meets all of the requirements of ASTM standard D3577-91 Type 2.
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/20 description: The image shows a registered trademark symbol. The symbol is a triangle on top of a circle. The word "REGISTERED" is written inside the circle.
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82600 Performance data of gloves to ASTM D 3577-91 Type 2 and FDA 1000 ml watertight test.
| TEST | ASTM D3577-91Type 2 | PROFEEL Synthetic Copolymer Surgical Gloves (Powdered) -refer to Attachment 7 of Device Test Report of Compliance |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 1.5 | Pass based on1) Single Sampling Plan, S-4, AQL 1.5,2) Multiple Sampling Plan, GII, AQL 2.5 |
| 2. Length (mm) | ||
| Size | ||
| 6½ | min 265 | 301 |
| 7 | min 265 | 299 |
| 7½ | min 265 | 298 |
| 8 | min 265 | 301 |
| 8½ | min 265 | 303 |
| 3. Palm Width (mm) | ||
| Size | ||
| 6½ | $83 \pm 6$ | 85 |
| 7 | $89 \pm 6$ | 92 |
| 7½ | $95 \pm 6$ | 96 |
| 8 | $102 \pm 6$ | 104 |
| 8½ | $108 \pm 6$ | 110 |
| 4. Single Wall Thickness (mm) | ||
| Finger | min 0.10 | 0.27 |
| Palm | min 0.10 | 0.25 |
| Cuff | min 0.10 | 0.20 |
| 5. Physical PropertiesType 2Before Aging : | ||
| Tensile Strength (MPa) | min 17 | 19.62 |
| Ultimate Elongation (%) | min 650 | 1108 |
| Stress at 500% Elongation (MPa) | max 7.0 | 1.92 |
| After Aging : | ||
| Tensile Strength (MPa) | min 12 | 16.35 |
| Ultimate Elongation (%) | min 490 | 1101 |
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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 Type 2.
9. Conclusion
g
This glove exceeds the ASTM D 3577-91 Type 2 requirements, and also meet FDA requirements for waterleak test on pinhole AQL.
Date Summary Prepared : July 16, 1998
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 1999
Mr. Yue Wah Chow Vice President QA/RA Wembley Rubber Products (M) Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
K982600 Re : Profeel Synthetic Copolymer Surgical Gloves Trade Name: (Powdered) Regulatory Class: I Product Code: KGO January 6, 1999 Dated: Received: January 11, 1999
Dear Mr. Yue Wah 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 legally marketed predicate 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 of the Act. The general controls provisions 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 Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (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: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Yue Wah Chow
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) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/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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ATTACHMENT 2
Applicant : Wembley Rubber Products (M) Sdn. Bhd.
| 510(k) Number (if known) : | K982600 |
|---|---|
| Device Name : | PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) |
Indications For Use :
:
- The surgeon's glove is a device made of synthetic copolymer intended to be 1. worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use OR
Stward by him
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K982600
§ 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).