(48 days)
The Powder Free Neoprene Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The Powder Free Neoprene Examination Gloves, Non Sterile meets all the The Towder 1160 - Neopandard D 3578 - 00 and FDA 21 CFR 800.20.
The provided document describes the WRP Asia Pacific Sdn Bhd "Powder Free Neoprene Examination Gloves, Non-Sterile". Here's an analysis of the acceptance criteria and the study data as requested:
Acceptance Criteria and Device Performance for Powder Free Neoprene Examination Gloves, Non-Sterile
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 00 | Meets |
| Physical Properties | ASTM D 3578 - 00 | Meets |
| Freedom from pinholes | ASTM D 3578 - 00 & FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | Meets (< 2 mg/glove) |
| Biocompatibility: | ||
| - Primary Skin Irritation | Primary Skin Irritation in Rabbits | Passes (Not a primary skin irritant) |
| - Dermal Sensitization | Dermal Sensitization (method not specified) | Passes (Not a contact sensitizer) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (Dimensions, Physical Properties, Pinhole, Powder-Free, Biocompatibility). The testing was conducted by WRP Asia Pacific Sdn Bhd in Malaysia. It is implied to be prospective testing carried out for the purpose of the 510(k) submission, as these are performance tests of the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (examination gloves) where performance is determined by objective physical and chemical testing against established standards, not through expert interpretation of images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. Performance is determined by objective measurements against established ASTM and FDA standards.
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 not an AI-powered diagnostic device, but a physical medical device (gloves).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used
The "ground truth" for the performance determination of these examination gloves were established industry standards and regulatory requirements:
- ASTM D 3578 - 00: Standard Specification for Rubber Examination Gloves. This standard dictates requirements for dimensions, physical properties, and freedom from pinholes.
- FDA 21 CFR 800.20: This regulation pertains to waterleak test on pinhole AQL (Acceptance Quality Limit).
- ASTM D 6124 - 00: Standard Test Method for Residual Powder on Medical Gloves.
- Biocompatibility Standards: Primary Skin Irritation in Rabbits and Dermal Sensitization tests (methods typically follow ISO 10993 series or equivalent guidelines).
8. The sample size for the training set
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the manufacturing and testing of examination gloves.
9. How the ground truth for the training set was established
Not applicable for the reasons stated in point 8.
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WRP Asia Pacific Sdn Bhd
AUG 1 6 2001
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALA YSIA
MALAYSIA
+60-3-8706 1486 TEL +60-3-8706 1485 FAX EML cyw wrp@wrpworld.com URL www.wrpworld.com
510(k) SUMMARY
Submitter: 1.0
| Name: | WRP Asia Pacific Sdn Bhd |
|---|---|
| Address: | Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru SalakTinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: June 14, 2001
Contact Person: 2.0
| Name: | Mr. Yue Wah, CHOW |
|---|---|
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
3.0 Name of the device:
| Trade Name: | 1. DermaSafe, and |
|---|---|
| 2. Multiple or Customer's Trade Name | |
| Device Name: | Powder Free Neoprene Examination Gloves, Non-Sterile |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
Identification of The Legally Marketed Device: 4.0
Class I patient examination gloves, 80LZA, powder free, that meets all the Class - 1 patient - C.TM standard D 3578 - 00 and FDA 21 CFR 800.20.
Description of The Device: 5.0
The Powder Free Neoprene Examination Gloves, Non Sterile meets all the The Towder 1160 - Neopandard D 3578 - 00 and FDA 21 CFR 800.20.
Page 1 of 3
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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, with the letters in white against a black background. To the right of the letters is the company name, "WRP Asia Pacific Sdn Bhd," in a smaller, sans-serif font.
Intended Use of the Device: 6.0
Clarron Eng All Dononna"
The Powder Free Neoprene Examination Gloves, Non-Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Neoprene Examination Gloves, Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICEPERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578 - 00 | Meets |
| Physical Properties | ASTM D 3578 - 00 | Meets |
| Freedom from pinholes | ASTM D 3578 - 00FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | 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, with the letters overlapping each other. To the right of the letters is the text "WRP Asia Pacific Sdn Bhd" in a smaller, sans-serif font. The logo is black and 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 Neoprene Examination Gloves, Non Sterile will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2001
Mr. Yue Wah Chow Head of Department of QA/RA WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, Sepang Selangor, MALAYSIA
K012048 Re : Powder Free Neoprene Examination Trade/Device Name: Gloves, Non Sterile Regulation Number: 880.6250 Regulatory Class: I Product Code: LZA Dated: June 14, 2001 Received: June 29, 2001
Dear Mr. Chow:
We have reviewed your Section 510(k) notification of intent to we have reviewed your boosed above and we have determined the market the device forly equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the encreate commerce prior to May 28, 1976, devices marketed in theormedical Device Amendments, or to the enactment ado on reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the reachar robe, subject to the general controls provisions of the Act. The general controls controls provisions of include requirements for annual provisions of the nee increat as as a manufacturing practice, labeling, and prchibitions against misbranding and adulteration.
If your device is classified (see above) into either class II II your device ID Crabblass III (Premarket Approval), it may (Special concrold) of Stimal controls. Existing major be subject to back address an be found in the Code of Fegulations artists, Title 21, Parts 800 to 895. A rederal negularies, and determination assumes compliance with substantlarly equivalenc aring Practice requirements, as set the carrent souality System Regulation (QS) for Medical Forch In the gailation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug through periodic QS inspections) one book assumptions. Failure to
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Page 2 - Mr. Chow
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 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 regulation (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 qeneral information on your responsibilities under the Act may be obtained 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,
Patricia Cicuente /for
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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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 inside of a black oval. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a sans-serif font. Below the text is the number sequence "1 4 7 8 1 7 V".
INDICATIONS FOR USE
Applicant:
WRP Asia Pacific Sdn Bhd
510(k) Number (if known):
Device Name:
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
Indications For Use:
The Powder Free Neoprene Examination Gloves, Non Sterile is a disposable I he Fowder Tree Teopreno Lhanhan intended for medical purposes that is worn device and is made or synthette race of amination between patient and examiner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
OR Over-The-Counter _____________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109)
§ 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.