(36 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
Here's a breakdown of the acceptance criteria and study information for the Rich Mountain Medical Products Inc. Disposable Vinyl Examination Glove, Powdered, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Device Performance (Test Results) | Notes |
|---|---|---|
| ASTM D5250-06 (General Requirements for Vinyl Patient Examination Gloves) | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0. | This standard covers various physical properties and dimensions of the gloves. |
| FDA 1000 ml Watertight Test based on ASTM D-5151-06 (Pinhole Leakage) | Conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements. | This test assesses the integrity of the glove to prevent liquid penetration. |
| Biocompatibility (Primary Skin Irritation) | Results showing no primary skin irritant reactions. | Assesses potential for skin irritation upon contact. |
| Biocompatibility (Skin Sensitization/Allergic Contact Dermatitis) | Results showing no sensitization reactions. | Assesses potential for allergic reactions upon repeated contact. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set:
- For Physical and Dimensions Testing (ASTM D5250-06): Inspection level S-2, AQL 4.0. (The exact numerical sample size is not explicitly stated, but these AQL and inspection levels define the sampling plan.)
- For FDA 1000 ml Watertight Test (ASTM D-5151-06): AQL 2.5, Inspection level I. (Again, the exact numerical sample size is not explicitly stated, but these AQL and inspection levels define the sampling plan.)
- For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but these are typically tested on a defined number of subjects or animal models according to biocompatibility guidelines.
- Data Provenance: The document does not explicitly state the country of origin of the data for the testing. It is implied that the testing was conducted by or for Rich Mountain Medical Products Inc. which is based in China. The studies are prospective as they were conducted specifically for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This information is not applicable to this submission. The device is a medical glove, and the evaluation relies on adherence to established ASTM standards and FDA guidelines for physical properties, barrier integrity, and biocompatibility, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
- This information is not applicable. The testing involves objective measurements against predefined standards and biological responses rather than subjective expert evaluations requiring 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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD devices that assist human readers in interpreting medical data. The device here is a physical product (a glove) and does not involve AI or human readers for diagnostic purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone study was not done. This concept applies to AI algorithms. The device is a physical product.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by objective measurements and standardized test methods as defined by ASTM D5250-06 and ASTM D-5151-06, along with established protocols for biocompatibility testing. There is no expert consensus, pathology, or outcomes data used in the typical sense for diagnostic devices.
8. The Sample Size for the Training Set:
- This information is not applicable. The device is a physical product, not an AI model, therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no training set for a physical product like a medical glove.
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K08 2444
SEP 3 0 2008
510(K) SUMMARY
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: Ms. Michelle Shih Rich Mountain Medical Products Inc. No. 8, Jiang Yin Road, Yitang Town Pizhou County, Jiangsu Province China
Date Summary Prepared: June 16, 2008
2. Name of the Device:
Rich Mountain Medical Products Inc. Disposable Vinyl Examination Glove, Powdered
3. Predicate Device Information:
Synmertex Co., Ltd. Disposable Powdered Vinyl Exam Gloves (K032190)
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, Powdered is substantially equivalent to the device manufactured by Synmertex Co., Ltd. (K032190).
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.
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, Powdered 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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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 symbol that resembles an abstract caduceus or a stylized representation of a human figure with flowing ribbons.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 2008
Ms. Michelle Shih Coordinator Rich Mountain Medical Products, Incorporated No. 8, Jiang Yin Road, Yitang Town Pizhou County, Jiangsu CHINA
Re: K082444
Trade/Device Name: Disposable Vinyl Examination Glove, Powdered Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: June 16, 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 vour 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,
Cuts
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
RICH MOUNTAIN MEDICAL PRODUCTS INC. Applicant:
208 2444 510(k) Number (if known):
Disposable Vinyl Examination Glove, Powdered Device Name:
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 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
6
Shule A. Murphy, 10
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.