(14 days)
A 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.
The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.
1. Acceptance Criteria and Device Performance:
| Characteristics | Standards (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319 – 00aEI | Meets |
| Physical Properties | ASTM D 6319 – 00dEI | Meets |
| Freedom from pinholes | ASTM D 6319 – 00dEIFDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 – 01 | < 2 mg/glove |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes (Not a primary skin irritant) |
| Dermal Sensitization | Passes (Not a contact sensitizer) |
2. Sample Size and Data Provenance (Test Set):
The document does not explicitly state a specific sample size used for the test set. Instead, it refers to the device meeting the requirements of ASTM D 6319 – 00aEI, ASTM D 6319 – 00dEI, FDA 21 CFR 800.20, and ASTM D 6124 – 01. These standards inherently specify their own sampling plans and methods for evaluating product characteristics.
The data provenance is implied to be from testing conducted by the manufacturer, WRP Specialty Products Sdn Bhd, in MALAYSIA, as part of their submission to the FDA. The data is retrospective in the sense that it represents results from prior testing to demonstrate compliance with established standards.
3. Number and Qualifications of Experts for Ground Truth (Test Set):
The study relies on established industry and regulatory standards (ASTM and FDA regulations) for acceptance criteria rather than individual expert establishment of ground truth for each test case. Therefore, there is no mention of a specific number of experts or their qualifications for establishing the ground truth for an independent test set in the traditional sense of a clinical study. The "ground truth" is defined by the parameters and thresholds set forth in the referenced standards.
4. Adjudication Method (Test Set):
There is no adjudication method described in the document as it pertains to an independent test set. The evaluation is based on meeting predefined performance criteria outlined in industry standards and FDA regulations, which typically involve laboratory testing and quantitative measurements against these criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The device is a patient examination glove, and the evaluation is based on material and performance characteristics against established standards, not on human interpretation or diagnostic accuracy where an MRMC study would be relevant.
6. Standalone Performance:
Yes, a standalone performance evaluation was done. The "Device Performance" column in the table directly reports the device's ability to meet the specified standards independently. The evaluation of glove characteristics like dimensions, physical properties, freedom from pinholes, powder-free status, and biocompatibility are intrinsic to the device itself and do not involve human-in-the-loop performance for their assessment.
7. Type of Ground Truth Used:
The ground truth used is based on established industry standards and regulatory requirements. Specifically, ASTM standards (D 6319 – 00aEI, D 6319 – 00dEI, D 6124 – 01) and FDA regulations (21 CFR 800.20) define the acceptable limits and performance characteristics for patient examination gloves. Biocompatibility testing results (Primary Skin Irritation in Rabbits, Dermal Sensitization) also serve as a form of ground truth based on established biological testing protocols.
8. Sample Size for the Training Set:
The document does not describe a "training set" in the context of machine learning or AI. This submission is for a medical device (patient examination gloves) where compliance is demonstrated through laboratory and material testing against established standards, not through iterative model training.
9. How Ground Truth for the Training Set Was Established:
As there is no training set in the context of AI/machine learning, the concept of establishing ground truth for a training set is not applicable to this device submission. The underlying principles for manufacturing and quality control of such gloves are guided by the same industry and regulatory standards that define the acceptance criteria for the final product.
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MAY 1 6 2002
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads as 'KQ21396'. The characters are written in a cursive style, with some connections between them. The overall impression is that of a handwritten code or identifier.
510(k) Summary
1.0 Submitter:
| Name: | WRP Specialty Products Sdn Bhd. |
|---|---|
| Address: | Lot 11, Jalan 2, Kawasan Perushaan Bandar Baru SalakTinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 9788 |
| Fax No.: | +60 3 8706 5020 |
Date of Summary Prepared: 30 APR 2002
2.0 Contact Person:
| Name: | V. Nadarajan |
|---|---|
| Phone No.: | +60 3 8706 9788 |
| Fax No.: | +60 3 8706 5020 |
3.0 Name of the device:
| Proprietary or Trade Name: | 1) Dermagrip, and |
|---|---|
| 2) Multiple or Customer's Trade Name | |
| Classification Name : | Patient Examination Gloves (per 21 CFR 880.6250) |
| Device Name : | Powder Free Purple Nitrile Examination Gloves, Non-Sterile |
Identification of The Legally Marketed Device: 4.0
Class I patient examination gloves, 80LZA, powder free, that meets all the
requirements of ASTM standard D 6319 - 00a" and FDA 21 CFR 800.20.
Description of The Device: 5.0
The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.
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Intended Use of the Device: 6.0
The patient examination glove is a disposable device intended for medical purposes The pation on the examiner's hand or finger to prevent contamination between patient and examiner.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Purple Nitrile Examination Gloves, Non Sterile is summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319 – 00aEI | Meets |
| Physical Properties | ASTM D 6319 – 00dEI | Meets |
| Freedom from pinholes | ASTM D 6319 – 00dEIFDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 – 01 | < 2 mg/glove |
| Biocompatability | Primary Skin Irritation in RabbitsDermal Sensitization | Passes(Not a primary skin irritant)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.
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 Purple Nitrile Examination Gloves, Non Sterile will perform according to the glove performance standards referenced 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Mr. V. Nadarajan Manager, QA/RA Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang Selangor Darul Ehsan, MALAYSIA
Re: K021396
Trade/Device Name: Dermagrip and Multiple Powder Free Purple Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: April 30, 2002 Received: May 2, 2002
Dear Mr. V. Nadarajan:
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 (1 mr 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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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 modifine and read a aves a detes and regulations administered by other Federal agencies. of the For all) - Posterall the Act's requirements, including, but not limited to: registration 1 od into compry That and 1 years 801); good manufacturing practice and fiscing (21 OF rear of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in one of 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 This letter will and in yours begine 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally in the 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the revents) existance 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,
Susan Runney
f
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
Applicant:
WRP Specialty Products Sdn Bhd
510(k) Number (if known):
Device Name:
FREE PURPLE NITRILE POWDER EXAMINATION GLOVES, NON STERILE
Indications For Use:
A 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Olen
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices KO21396 510(k) Number ________________________________________________________________________________________________________________________________________________________________
OR Prescription Use (Per 21 CFR 801.109)
Over-The-Counter
Page 1 of 1
§ 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.