(75 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 Classince by I DA's Gelleral Hoopication Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
The provided text describes a 510(k) submission for Supermax Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves. It details the device, its intended use, comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence.
Here's an analysis based on your request, highlighting that this is for a medical device (glove), not an AI/software device, so many of your requested fields related to AI/software studies are "Not Applicable".
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D-5250-06e1 and FDA) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: (Specifics not detailed, but implied by ASTM D-5250-06e1) | "All testing meets requirements for physical and dimensions testing conducted on gloves." |
| Freedom from Holes (FDA 1000 ml Water Fill Test): AQL 2.5, Inspection Level I | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements." |
| Primary Skin Irritation: No primary skin irritant reactions | "Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant... reactions." |
| Skin Sensitization (Allergic Contact Dermatitis): No sensitization reactions | "Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no... sensitization reactions." |
| Residual Powder (for "powder-free" claim): No more than 2 mg powder per glove (based on ASTM D-6124-06) | "A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection is conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." |
| General Manufacturing Quality: Inspection level S-2, AQL 4.0 (for general defects) | "Inspection level S-2, AQL 4.0." |
| Biocompatibility: (Implied by primary skin irritation and sensitization tests) | Met (as stated in conclusions: "biocompatibility requirements and labeling claims as shown by data in Section 7.") |
| Labeling Claims: No special claims, no hypoallergenic claim | "There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels." |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For the FDA 1000 ml Water Fill Test: Sampling based on AQL 2.5, Inspection Level I (specific number of gloves not provided, but determined by the AQL standard).
- For general physical/dimensional testing: Inspection level S-2, AQL 4.0 (specific number of gloves not provided, but determined by the AQL standard).
- For Primary Skin Irritation and Skin Sensitization: Not specified, but standard biological tests would use a certain number of subjects/samples.
- For Residual Powder Test: Not specified, but based on ASTM D-6124-06.
- Data Provenance: Not explicitly stated, but the tests were conducted by the manufacturer (Supermax Plastic Products Co., Ltd. in China) and likely refer to internal testing data. It is a retrospective evaluation of manufactured batches.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device (glove) evaluation, not an AI/software diagnostic tool. Ground truth is established by objective physical and chemical measurements (e.g., water leak, powder weight) and biological tests, not expert interpretation of outputs.
4. Adjudication method for the test set
- Not Applicable. As per point 3, ground truth is established by objective measurements and standardized tests, not by expert consensus 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
- Not Applicable. This is a physical device (glove); there are no "human readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device (glove), not an algorithm.
7. The type of ground truth used
- The ground truth is established through adherence to recognized industry standards (ASTM D-5250-06e1, ASTM D-6124-06) and FDA-prescribed test methods (FDA 1000 ml Water Fill Test).
- It involves objective physical measurements, chemical analysis, and biological safety testing (primary skin irritation and sensitization).
8. The sample size for the training set
- Not Applicable. This is not an AI/ML model that requires a training set. The "training" in manufacturing would refer to process control and quality assurance over production runs, not data for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set in the context of an AI/ML model for this device.
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FEB 2 8 2010
EXHIBIT #1 Page 1 of 2
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: K093797
1. Owner's Identification:
Mr. Zhanmin Lv Supermax Plastic Products Co., Ltd. 314 Dragon River East Road, Luquan, Hebei Province, China 050000 Date Summary Prepared: November 2, 2009
2. Name of the Device:
Supermax Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves (Yellow, White)
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd Billianing Group Vinyl Patient Examination Gloves (K992861).
4. Device Description:
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 Classince by I DA's Gelleral Hoopication Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
5. Intended Use:
A patient examination glove is disposable device intended for medical purpose that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.
6. Comparison to Predicate Devices:
Supermax Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White) is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Powder-Free (yellow) Vinyl Patient Examination Gloves.
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Kog3797
EXHIBIT #1 Page 2 of 2
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Supermax Plastic Products Co., Ltd.'s glove production are based on ASTM D-5250-06e1. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test 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.
A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
8. Labeling:
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
9. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
10. Conclusions:
Supermax Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White) conform fully to ASTM D-5250-06e1 standard as well as applicable 21 CFR 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. The device herein mentioned is as safe, as effective, and performs as well as or better than the predicate device.
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Supermax Plastic Products Company, Limited C/O Ms. Jie Liu Project Manager Surprotect Incorporated 3973 Schaefer Avenue Chino, California 91710
FEB 2 3 2010
Re: K093797
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 2, 2009 Received: December 10, 2009
Dear Ms. Liu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Liu
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sueen Runnes
Anthony D. Watson, B.S., M.S., M.B.A. 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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Attachment A
INDICATION FOR USE
K 093797
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
Supermax Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves (Yellow, White)
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Elishth F. Clmerio-Will
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
11093797 510(k) Number:
Prescription Use (Part 21 CFR 801 Subpart D) AND/ OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (21CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent 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.