(116 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
The provided text describes a 510(k) summary for Rich Mountain Medical Products Inc.'s Disposable Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green Color. This document is a premarket notification for a medical device and therefore focuses on demonstrating "substantial equivalence" to a predicate device rather than providing detailed acceptance criteria and a comprehensive study that proves the device meets those criteria in the way a more advanced AI/ML device would.
However, I can extract the relevant information from the document to construct the closest possible answer based on the provided text, interpreting the "device performance" in terms of compliance with relevant standards and tests for gloves.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|
| ASTM D5250-06 (Physical and Dimensions Testing) | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0. Conforms fully. |
| FDA 1000 ml Watertight Test based on ASTM D-5151-06 (Pinhole integrity) | Conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements. Meets pinhole FDA requirements. |
| Biocompatibility - Primary Skin Irritation | Results showing no primary skin irritant reactions. |
| Biocompatibility - Skin Sensitization (allergic contact dermatitis) | Results showing no sensitization reactions. |
| ASTM D6124-06 (Residual Powder Test for "powder-free" claim) | Conducted at finished inspection to ensure gloves contain no more than 2 mg powder per glove. |
2. Sample size used for the test set and the data provenance
- ASTM D5250-06 (Physical and Dimensions Testing): Inspection level S-2, AQL 4.0. (Specific sample size not provided, but implies standard sampling per ASTM).
- FDA 1000 ml Watertight Test based on ASTM D-5151-06 (Pinhole integrity): AQL 2.5, Inspection level I. (Specific sample size not provided, but implies standard sampling per ASTM).
- Biocompatibility (Primary Skin Irritation and Skin Sensitization): Not specified.
- Data Provenance: Not explicitly stated, but assumed to be from tests conducted by the manufacturer, Rich Mountain Medical Products Inc. No mention of country of origin for the testing data itself, but the manufacturer is in China. Retrospective/Prospective is not applicable in this context as these are manufacturing quality control tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a medical glove, "ground truth" is established by adherence to predefined engineering and biological standards (e.g., ASTM standards for physical properties, ISO standards for biocompatibility). The "truth" is whether the glove meets the defined pass/fail criteria of these standardized tests, not an expert's interpretive assessment.
4. Adjudication method for the test set
Not applicable. The tests involve objective measurements against established criteria, not subjective expert judgment that would require adjudication.
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 device is a disposable medical glove, not an AI/ML-driven diagnostic or interpretative system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI. It is a physical device.
7. The type of ground truth used
The ground truth used is based on:
- Engineering standards (e.g., ASTM for physical dimensions, tensile strength, elongation).
- Performance standards (e.g., ASTM for watertightness/pinhole integrity).
- Biocompatibility standards (e.g., for skin irritation and sensitization).
- Chemical residue standards (e.g., for powder content).
8. The sample size for the training set
Not applicable. This device does not involve a training set in the context of AI/ML. Manufacturing processes are optimized over time, but this doesn't constitute a "training set" in the sense of AI.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" in the AI/ML sense for this device. The ground truth for the device's performance is established by the specified ASTM and FDA testing standards.
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SEP 2 6 2008
REVISED 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(K) safety and effectiveness information is being submitted in Accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(K) number is:
1. Submitter's Identification:
Michelle Shih Rich Mountain Medical Products Inc. No. 8, Jiang Yin Road, Yitang Town Pizhou County, Jiangsu Province China
Date Summary : April 15, 2008
2. Name of the Device:
Rich Mountain Medical Products Inc. Disposable Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green Color
3. Predicate Device Information:
Canopus Medical Supply Company Limited. Disposable Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera, Green Color (K023728)
4. Device description:
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
5. Intended 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.
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6.Comparison to Predicate Devices:
Rich Mountain Medical Products Inc.'s
Disposable Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green Color is substantially equivalent to the device manufactured by Canopus Medical Supply Company Limited. (K023728).
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Rich Mountain Medical Products Inc.'s glove production are Based on ASTM D5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0.
The FDA 1000 ml Watertight Test based on ASTM D-5151-06 was also conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
A residual Powder test that based on ASTM D6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per gloves)
8. Discussion of Clinic Tests Performed:
Not applicable - There is no Hypoallergenic Claim.
9. Conclusions:
Rich Mountain Medical Products Inc's Disposable Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green Color conform fully to ASTM D-5250-06 standard as well as applicable 21CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7.
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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 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 with its wings spread, rendered in a thick, black line.
Public Health Service
SEP 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Michelle Shih Coordinator Rich Mountain Medical Products, Incorporated No. 8, Jiang Yin Road, Yi Tang Town Pizhou County, Jiangsu CHINA
Re: K081539
Trade/Device Name: Disposable Powder Free Vinyl Synthetic Exam Glove, With Aloe Vera, Green Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 15, 2008 Received: September 18, 2008
Dear Ms. Shih:
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 - Ms. Shih
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 (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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Manuel Lender for II
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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Indications for Use
Applicant: RICH MOUNTAIN MEDICAL PRODUCTS INC.
510(k) Number (if known): APPLIED
Device Name: Disposable Powder Free Vinyl Synthetic Exam Gloves, With
Aloe Vera, Green Color
Indications for Use:
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081534
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.