(316 days)
The patient examination glove is a disposable device and is made of natural The patient exammation grove is a 'displace' worn on the examiner's hand of furoer to prevent contamination between patient and examiner.
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 - 01aE2 and FDA 21 CFR 800.20.
The provided text describes a 510(k) summary for "Powder Free Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim". This is a medical device application for examination gloves, which falls under a different category than typical AI/ML medical devices that require the types of studies listed in the prompt.
Therefore, many of the requested elements are not applicable to this 510(k) submission. Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | < 2 mg/glove |
| Protein Level | ASTM D 5712 - 95 | < 50 $\mu$ g/g |
| Biocompatibility | Primary Skin Irritation in RabbitsDermal Sensitization | Passes (Not a primary skin irritant)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 specify sample sizes for each test listed in the characteristics table.
- The data provenance is not explicitly stated as country of origin, but the submitting company is WRP Specialty Products Sdn Bhd from Malaysia. The tests refer to ASTM and FDA standards, which are international/US standards. The nature of these tests (e.g., physical properties, chemical analysis) generally implies laboratory testing rather than data from human patients or retrospective studies in the way an AI/ML device would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The ground truth for these device characteristics is established by scientific methodologies and standardized test procedures (e.g., ASTM standards, chemical analysis), not by expert consensus in the clinical sense.
4. Adjudication method for the test set
- Not applicable. The "adjudication method" as typically understood for clinical studies (e.g., 2+1, 3+1) is not relevant for laboratory and performance testing of physical devices like gloves.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on standardized laboratory testing and analytical methods as defined by ASTM and FDA regulations. For example:
- Dimensions: Measured against specified tolerances in ASTM D 3578 - 01aE2.
- Physical Properties: Tested according to ASTM D 3578 - 01aE2 protocols.
- Freedom from pinholes: Tested using water leak methods as per ASTM D 3578 - 01aE2 and FDA 21 CFR 800.20 (AQL).
- Powder-Free: Measured using gravimetric methods as per ASTM D 6124 - 01.
- Protein Level: Measured using chemical assay methods as per ASTM D 5712 - 95.
- Biocompatibility: Tested on rabbits (Primary Skin Irritation) and humans (Dermal Sensitization) using established toxicology protocols.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.
{0}------------------------------------------------
MAY 11 2004
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:
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-X, and |
|---|---|
| 2) Multiple or Customer's Trade Name | |
| Classification Name : | Patient Examination Gloves (per 21 CFR 880.6250) |
| Device Name : | Powder Free Latex Examination Gloves Coated with |
| Vitamin E, and with Protein Content Labeling Claim | |
| (50 Micrograms or less) |
Identification of The Legally Marketed Device: 4.0
Class I patient examination gloves, 80LYY, powder free, that meets all the
requirements of ASTM standard D 3578 – 01a 22 and FDA 21 CFR 800.20.
Description of The Device: 5.0
:
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 - 01aE2 and FDA 21 CFR 800.20.
{1}------------------------------------------------
Intended Use of the Device: 6.0
The Powder Free Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim are disposable device intended for medical purposes that is worn 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 Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | < 2 mg/glove |
| Protein Level | ASTM D 5712 - 95 | < 50 $\mu$ g/g |
| 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 Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim 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.
{2}------------------------------------------------
Image /page/2/Picture/1 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 top half of the circle. Inside the circle is a symbol that resembles a stylized caduceus, with three lines representing the snake and a single line representing the staff.
:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2004
Mr. Nadarajan Venugopal Manager, Quality Assurance Regulatory Affairs WRP Specialty Products Sdn Bhd Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Re: K032016
Trade/Device Name: Dermagrip- X Powder Free Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim (Contains 50 Micrograms or Less of Total Water Extractable Protein Per GRAM) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class; I Product Code: LY Y Dated: April 6, 2004 Received: April 12, 2004
Dear Mr. Venugopal:
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 NE ), it has obe found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In
{3}------------------------------------------------
Page 2 - Mr. Venugopal
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 incall that I Dr mai made statutes and regulations administered by other Federal agencies. or the rice of any I edenal the Act's requirements, including, but not limited to: registration 1 od intist comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and ifsime (21 CF CF results in the quality systems (QS) 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 premairer notificate 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), If you desire specific at Compliance at (301) 594-4618. Also, please note the regulation contitled. "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,
Susan Runno
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
{4}------------------------------------------------
INDICATIONS FOR USE
:
| Applicant: | WRP Specialty Products Sdn Bhd |
|---|---|
| 510(k) Number (if known): | K032016 |
| Device Name: | POWDER FREE LATEX EXAMINATIONGLOVES COATED WITH VITAMIN E, ANDWITH PROTEIN CONTENT LABELING CLAIM(CONTAINS 50 MICROGRAMS OR LESS OFTOTAL WATER EXTRACTABLE PROTEINPER GRAM) |
Indications For Use:
The patient examination glove is a disposable device and is made of natural The patient exammation grove is a 'displace' worn on the examiner's hand of furoer to prevent contamination between patient and examiner.
Concurrence of CDRH, Office of Device Evaluation (ODF)
| Prescription Use(Per 21 CFR 801.109) | OR Over-The-Counter ✓ |
|---|---|
| Kei Mulry | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital,Infection Control, Dental Devices | |
| 510(k) Number: | K032016 |
Page I 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.