(32 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 Ltd. Disposable Vinyl Synthetic Examination Gloves, Powder Free, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Performance Requirement | Reported Device Performance |
|---|---|---|
| ASTM D5250-06 (Physical and Dimensions Testing) | Meets all requirements | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0." |
| FDA 1000 ml Watertight Test (ASTM D-5151-06) | AQL 2.5, Inspection level I | "meeting these requirements." |
| Primary Skin Irritation | No primary skin irritant reactions | "no primary skin irritant reactions" |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | "no...sensitization reactions" |
| Residual Powder (ASTM D6124-06 for Starch) | No more than 2 mg powder per glove (for "powder-free" claim) | "to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per gloves)" |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size:
- 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 is defined by the AQL and inspection level, which are standard sampling methods).
- 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 is defined by these parameters).
- For Primary Skin Irritation and Skin Sensitization: Not specified beyond "testing was conducted."
- For Residual Powder Test: Not specified beyond "samplings."
-
Data Provenance: The manufacturing company is Rich Mountain Medical Products Ltd., located in China (Jiangsu Province). The testing appears to have been conducted by or for the manufacturer. The data is retrospective relative to the submission date, as it reflects tests performed on manufactured batches of gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. This is a Class I medical device (patient examination glove), and the testing involves objective measurement against performance standards (e.g., physical properties, watertight integrity, chemical residue, biocompatibility), not subjective assessments requiring expert consensus on a "ground truth" for diagnostic or interpretative accuracy.
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective measurements against established standards, not subjective assessments 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 diagnostic or AI-assisted interpretation devices. The device in question is a physical barrier (examination glove), and its effectiveness is measured by its physical properties and barrier integrity, not by human reader performance or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is defined by:
- Established ASTM Standards: D5250-06 (Physical and Dimensions), D-5151-06 (Watertight), D6124-06 (Residual Powder).
- Biocompatibility Testing: Results showing "no primary skin irritant or sensitization reactions."
- Regulatory Requirements: FDA's 1000 ml Watertight Test and good manufacturing practices.
These standards and direct measurements form the objective "ground truth" against which the glove's performance is evaluated.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the conventional sense. The "training" for the manufacturing process would be quality control and adherence to manufacturing specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML component, there is no "training set" or "ground truth" for such a set. The manufacturing process's "ground truth" is adherence to quality control parameters and the specifications outlined in the ASTM standards.
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K08.2443
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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:
Michelle Shih Rich Mountainn Medical Products Ltd. No. 8, Jiang Yin Road, Yitang Town Pizhou County, Jiangsu Province China
Date Summary Prepared: July 07, 2008
2. Name of the Device:
Rich Mountain Medical Products Ltd. Disposable Vinyl Synthetic Examination Gloves, Powder Free
3. Predicate Device Information:
Safehealth Medical Supply Corp Vinyl Examination Glove,Powder Free (K955091)
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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K082443
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6.Comparison to Predicate Devices:
Rich Mountain Medical Products Inc's Disposable Vinyl Synthetic Examination Gloves, powder free is substantially equivalent to the device manufactured by Safehealth Medical Supply Corp. (K955091).
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 Synthetic Examination Gloves, 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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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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.
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: K082443
Trade/Device Name: Disposable Vinyl Synthetic Examination Gloves Powder Frec Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: July 7, 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 (OS) 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,
H. Armueler Rend mty
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:
510(k) Number (if known): APPLIED | | ( ( ( 2 4 4 3
Device Name: Disposable Vinyl Synthetic 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 --------Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
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510(k) Number: K082443
§ 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.