(86 days)
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile, meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.
Here's a breakdown of the acceptance criteria and study information for the WRP Asia Pacific Sdn Bhd surgical gloves, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA (Implicit in "Meets") | REPORTED DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 3577 - 01aF2 | Meets ASTM D 3577 - 01aF2 | Meets |
| Physical Properties | ASTM D 3577 - 01aF2 | Meets ASTM D 3577 - 01aF2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aF2, FDA 21 CFR 800.20 | Meets ASTM D 3577 - 01aF2, FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | < 2 mg/glove | < 2 mg/glove |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in Rabbits | Not a primary skin irritant | Passes (Not a primary skin irritant) |
| Biocompatibility (Dermal Sensitization) | Dermal Sensitization | Not a contact sensitizer | Passes (Not a contact sensitizer) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each test. However, it indicates that the device performance "Meets" the specified ASTM and FDA standards. These standards typically define the sampling plans and acceptable quality limits (AQLs) for testing. For example, for "Freedom from pinholes," FDA 21 CFR 800.20 specifies water leak test requirements and AQLs.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are performed in accordance with international and US standards (ASTM, FDA), implying established testing methodologies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" for this medical device (surgical gloves) is established by meeting predefined scientific and engineering performance standards (e.g., tensile strength, elongation, freedom from pinholes, powder content, biocompatibility) as outlined in ASTM and FDA regulations, not by expert consensus on clinical interpretation or outcomes in the same way an AI diagnostic tool would.
4. Adjudication Method for the Test Set
This is not applicable and not provided. The performance assessment relies on standardized laboratory testing protocols, not on human adjudication of results in the way a diagnostic study would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is evaluated. Surgical gloves are a manufacturing product, and their performance is assessed through laboratory testing against established specifications.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a conceptual sense, the performance described is "standalone" in that it refers to the intrinsic physical and chemical properties of the glove itself, as measured by standard tests, independent of human interaction during operational use. There is no AI algorithm involved in this device.
7. The Type of Ground Truth Used
The "ground truth" for this device is the predefined specifications and acceptable limits established by recognized standards such as ASTM D 3577, FDA 21 CFR 800.20, and ASTM D 6124. For biocompatibility, it's the biological response criteria (e.g., "not a primary skin irritant," "not a contact sensitizer") determined through in-vivo testing (rabbits).
8. The Sample Size for the Training Set
This information is not applicable. Surgical gloves are not an AI/machine learning device; therefore, there is no "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 device.
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Image /page/0/Picture/0 description: The image contains the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, enclosed within a rounded shape. To the right of the logo is the full name of the company, "WRP Asia Pacific Sdn Bhd", also in a bold, sans-serif font. Below the company name is the number "147817 V".
DEC 1 7 2003
510(k) SUMMARY
1.0 Submitter:
| Name: | WRP Asia Pacific Sdn Bhd |
|---|---|
| Address: | Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi,43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: 16 SEP 2003
Contact Person: 2.0
| Name: | Mr. Terence Lim |
|---|---|
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
3.0 Name of the device:
| Trade Name: | 1. Profeel, and2. Multiple or Customer's Trade Name |
|---|---|
| Device Name: | Powder Free, Polymer Coated Polyisoprene Surgical Glove,Sterile |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |
4.0 Identification of The Legally Marketed Device:
Class I Powder Free Synthetic rubber latex surgeon's gloves, 79KGO, that meets all
the requirements of ASTM standard D 3577 -- 01a22 Type 2 and FDA 21 CFR 800.20
5.0 Description of The Device:
.
The Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile, meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.
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Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a stylized font, with the words "WRP Asia Pacific Sdn Bhd" to the right of the letters. Below the company name is the number 147817V.
Intended Use of the Device: 6.0
The Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile, is made of synthetic rubber latex 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.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICEPERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3577 - 01aF2 | Meets |
| Physical Properties | ASTM D 3577 - 01aF2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aF2FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | Meets< 2 mg/glove |
| Biocompatability | Primary Skin Irritation inRabbits | Passes(Not a primary skin irritant) |
| Dermal Sensitization | Passes(Not a contact sensitizer) |
Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
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Image /page/2/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font inside of a black oval. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "147817V".
Image /page/2/Picture/1 description: The image shows a sequence of handwritten characters. The characters are 'K032942'. The characters are written in a cursive style, with some of the characters connected to each other. The image is a close-up of the characters, and the background is white.
Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Conclusion 10.0
It can be concluded that the Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 image of an eagle or other bird with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2003
Mr. Terence Lim Associate Manager, Quality Assurance Regulatory Affairs WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang, Selangor Darul Ehsan MALAYSIA
Re: K032942
Trade/Device Name: Profeel and Multiple Customer's Trade Names, Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: September 16, 2003 Received: September 22, 2003
Dear Mr. Lim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lim
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease that FDA has made a determination that your device complies with other requirements mount that 1 Dr. Mar in and regulations administered by other Federal agencies. of the Flor of arry a vith all the Act's requirements, including, but not limited to: registration 1 ou intest comply with a807); labeling (21 CFR Part 801); good manufacturing practice and ilsuing (2 = set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a premainten libated 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Ches
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, with the letters arranged in a slightly curved shape. To the right of the logo is the company name, "WRP Asia Pacific Sdn Bhd," in a smaller, sans-serif font. Below the company name is the number "147817V".
INDICATIONS FOR USE
Applicant: WRP Asia Pacific Sdn Bhd
510(k) Number (if known): K032942
Device Name: PROfeel and Multiple Customer's Trade
Names, POWDER FREE, POLYMER COATED
POLYISOPRENE SURGICAL GLOVES,
STERILE
Indications For Use:
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
Martha T. O'Lone
510(k) Number: K032942
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usc (Per 21 CFR 801.109) OR
Over-The-Counter ✓
§ 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).