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.

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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Rich Mountain Medical Products Inc. Disposable Vinyl Examination Glove, Powder Free. The focus of the provided text is to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would be typical for more complex medical devices.

Therefore, many of the requested elements pertaining to clinical studies and associated metrics (like sample sizes for test sets, expert consensus, MRMC studies, training set details) are not applicable to this type of device and submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on meeting established industry standards and regulatory requirements for patient examination gloves.

Acceptance Criteria (Standard / Requirement)	Reported Device Performance
Material Strength/Physical Properties (ASTM D5250-06)	"All testing meets requirements for Physical and Dimensions Testing conducted on gloves. Inspection level S-2, AQL 4.0."
Pinhole/Watertightness (FDA 1000 ml Watertight Test based on ASTM D-5151-06)	"conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements."
Biocompatibility (Primary Skin Irritation and Skin Sensitization)	"conducted with results showing no primary skin irritant or sensitization reactions."
Powder-Free Claim (ASTM D6124-06 for Starch)	"conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per gloves)"
Predicate Device Equivalence	"substantially equivalent to the device manufactured by Synmertex Company Limited (K032172)."
General Regulatory Compliance	"conform fully to ASTM D-5250-06 standard as well as applicable 21CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims."

Study Details for Demonstrating Acceptance Criteria (Non-Clinical Tests)

The "study" described here is a series of non-clinical, laboratory-based tests.

Sample size used for the test set and data provenance:
- ASTM D5250-06 (Physical and Dimensions): "Inspection level S-2, AQL 4.0." (Specific sample size not explicitly stated, but statistical sampling plan indicated).
- ASTM D-5151-06 (Watertightness): "samplings of AQL 2.5, Inspection level I" (Specific sample size not explicitly stated, but statistical sampling plan indicated).
- Biocompatibility (Skin irritation/sensitization): Sample size for this biological testing is not provided.
- ASTM D6124-06 (Residual Powder): Sample size for this testing is not provided.
- Data Provenance: The tests were performed by Rich Mountain Medical Products Inc. (manufacturer), presumably in China (country of origin for the submitter). These are retrospective tests conducted on samples of manufactured gloves.
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 tests is defined by the objective pass/fail criteria of the ASTM standards and FDA requirements, which do not typically involve human expert adjudication in the same way as, for example, image interpretation.
Adjudication method for the test set: Not applicable. Results are based on objective measurements and comparison to defined thresholds within the standards.
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 diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used: The ground truth is defined by the objective, quantitative measurements against established thresholds and specifications outlined in the referenced ASTM standards (D5250-06, D5151-06, D6124-06) and FDA requirements (e.g., biocompatibility criteria, pinhole limits, powder limits).
The sample size for the training set: Not applicable. This device does not use an algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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OCT 1 4 2008

510(K) SUMMARY

KOC 247

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 No. 8, Jiang Yin Road, Yitang Town Pizhou County, Jiangsu Province China

Date Summary Prepared: June 23, 2008

2. Name of the Device:

Rich Mountain Medical Products Inc. Disposable Vinyl Examination Glove, Powder Free

3. Predicate Device Information:

Synmertex Company Limited Disposable Powder Free Vinyl Exam Glove (K032172)

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 Vinyl Examination Glove, Powder Free is substantially equivalent to the device manufactured by Synmertex Company Limited(K032172) .

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 Vinyl Examination Glove, Powder Free 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. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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Public Health Service

OCT 1 4 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, Yitang Town Pizhou County, Jiangsu CHINA

Re: K082447

Trade/Device Name: Disposable Vinyl Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Codc: LYZ Dated: June 23, 2008 Received: August 25, 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,

Chiu Lin, 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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Applicant: RICH MOUNTAIN MEDICAL PRODUCTS INC.

510(k) Number (if known): APPLIED

Device Name: Disposable Vinyl Examination Gloves, Powder Free

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.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

OR Over-The-C
(21 CFR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H. Murphy, R.D.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082447

Regulation Number and Section

§ 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.