(72 days)
The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera 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.
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 Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera (Trade Names: Aloetouch, Multiple or Customer's Trade Name)
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA | DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 3577 - 01aE2 | Meets ASTM D 3577 - 01aE2 | Meets (reported as "Meets") |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets ASTM D 3577 - 01aE2 | Meets (reported as "Meets") |
| Freedom from pinholes | ASTM D 3577 - 01aE2 | Meets ASTM D 3577 - 01aE2 and FDA 21 CFR 800.20 for water leak test on pinhole AQL | Meets (reported as "Meets") |
| FDA 21 CFR 800.20 | |||
| Powder-Free | ASTM D 6124 - 01 | < 2 mg/glove | < 2 mg/glove (reported as "Meets < 2 mg/glove") |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation in Rabbits | Passes (Not a primary skin irritant) | Passes (Not a primary skin irritant) |
| Biocompatibility: Dermal Sensitization | Dermal Sensitization | Passes (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 specific sample sizes for each test in the acceptance criteria. It refers to standards like ASTM D 3577 - 01aE2, ASTM D 6124 - 01, and FDA 21 CFR 800.20, which would dictate the sample sizes required for those tests. The data provenance is not specified beyond the fact that the applicant (WRP Asia Pacific Sdn Bhd) is located in Malaysia. The nature of the tests (e.g., physical properties, biocompatibility) suggests these would be laboratory-based, controlled studies, implying a prospective collection for these specific performance tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The "ground truth" for these types of device performance characteristics is typically established by adherence to recognized international (e.g., ASTM) and national (e.g., FDA) standards, rather than direct expert consensus on individual test results. The device either "Meets" or "Passes" the quantitative and qualitative requirements set forth by these standards.
4. Adjudication Method for the Test Set
No explicit adjudication method is mentioned. Given the nature of objective performance tests against standards, adjudication in the traditional sense (e.g., 2+1, 3+1 for clinical endpoints) is not applicable. The device's performance is measured against predefined numerical and qualitative thresholds within the specified standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. Surgical gloves are physical barriers, and their effectiveness is assessed through physical and biological testing, not through human interpretation of cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this concept is not applicable to a surgical glove. The device itself is a physical product, not an algorithm, and does not require human-in-the-loop performance in its assessment. Its performance is assessed inherently as a standalone physical device.
7. The Type of Ground Truth Used
The ground truth used is primarily based on established industry standards and regulatory requirements. Specifically:
- ASTM (American Society for Testing and Materials) standards (D 3577 - 01aE2, D 6124 - 01)
- FDA regulations (21 CFR 800.20)
- Standard biocompatibility tests (Primary Skin Irritation in Rabbits, Dermal Sensitization), which have established pass/fail criteria.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This device is a physical product, not an AI or machine learning model. Therefore, there is no training set as understood in the context of AI/ML development. The "training" for such a device involves manufacturing processes and quality control that ensure consistency with the established standards.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable. The manufacturing process is designed to produce gloves that inherently meet the referenced standards, which serve as the "ground truth" for product quality and performance throughout manufacturing.
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Image /page/0/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" written to the right of the letters. Below the company name is the number 147817V.
NOV - 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 1557 |
Date of Summary Prepared: 25 AUG 2003
2.0 Contact Person:
| Name: | Mr. Terence Lim |
|---|---|
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1557 |
3.0 Name of the device:
| Trade Name: | 1. Aloetouch, and2. Multiple or Customer's Trade Name |
|---|---|
| Device Name: | Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera. |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |
Identification of The Legally Marketed Device: 4.0
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 Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 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 bold, sans-serif font, enclosed in a black oval shape. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "147817 V".
6.0 Intended Use of the Device:
The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera 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 Neoprene Surgical Gloves, Sterile, Turquoise Colour and coated with Aloe Vera are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICEPERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3577 - 01aE2 | Meets |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aE2FDA 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) |
8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
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 black oval shape, followed by the text "WRP Asia Pacific Sdn Bhd" in a bold, sans-serif font. Below the company name is the number "147817 V".
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.
10.0 Conclusion
It can be concluded that the Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2003
Mr. Terence Lin 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: K032647
Trade/Device Name: Aloetouch Powder Free Neoprene Surgical Gloves, Sterile, Turquoise Color Coated with Aloe Vera Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 25, 2003 Received: August 27, 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 mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the 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 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 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,
Susakunos
fr. Shih-Li Liu, Ph.D.
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 stylized font, followed by the words "WRP Asia Pacific Sdn Bhd" in a more standard font. Below the company name is the number 147817V.
INDICATIONS FOR USE
Applicant:
WRP Asia Pacific Sdn Bhd
510(k) Number (if known):
$\k_{0.32647}$
Device Name:
FREE NEOPRENE POWDER SURGICAL STERILE, GLOVES. TURQUOISE COLOUR AND COATED WITH ALOE VERA
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.
Pat By Lales Board Chy 18/6/03
510(k) Number:
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109) 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).