(61 days)
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.
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 D5250-00E4.
The provided text describes a 510(k) submission for "Shanghai Antares Industries Inc. Disposable Powder Free Vinyl Synthetic Exam Gloves, With Vitamin Complex, Nopal and Lanolin (Blue Color)". Medical gloves are Class I devices and generally demonstrate substantial equivalence through performance testing against recognized standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Test Standard/Method) |
|---|---|
| Physical and Dimensions Testing | Meets requirements based on ASTM D5250-00E4, Inspection level S-2, AQL 4.0. |
| Watertight Integrity (Pinhole) | Meets requirements based on FDA 1000 ml Watertight Test (ASTM D-5151-99), samplings of AQL 2.5, Inspection level I. |
| Powder-Free Claim | Meets "powder-free" claim (no more than 2 mg powder per glove) based on ASTM D6124-01 for Starch. |
| Primary Skin Irritation | Results show no primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | Results show no sensitization reactions. |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific sample size is not explicitly stated but is implicitly defined by the ASTM D5250-00E4 standard and the AQL.
- Watertight Integrity: Inspection level I, AQL 2.5. The specific sample size is not explicitly stated but is implicitly defined by the ASTM D-5151-99 standard and the AQL.
- Powder-Free Claim: Not explicitly stated, but the test (ASTM D6124-01) is conducted at "finished inspection".
- Primary Skin Irritation and Skin Sensitization: Sample size for these biocompatibility tests is not explicitly mentioned.
The data provenance is prospective manufacturing testing of the Shanghai Antares Industries Inc. gloves. The country of origin of the data is implicitly China, where the manufacturer (Shanghai Antares Industries Inc.) is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI algorithm would. The "ground truth" is established by the objective measurement against the specified ASTM standards and FDA test methods. Therefore, the concept of "number of experts" or their "qualifications" for ground truth establishment is not applicable here.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against established standards, not subjective interpretations 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 medical device (examination gloves), not an AI algorithm for diagnosis or interpretation that would typically require an MRMC study comparing human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on objective performance standards and test methodologies established by ASTM (American Society for Testing and Materials) and FDA. For example:
- Physical properties (dimensions, tensile strength) are objectively measured against limits defined in ASTM D5250-00E4.
- Watertight integrity (pinhole) is objectively measured against the criteria in ASTM D-5151-99.
- Powder content is objectively measured against the limit of 2 mg per glove using ASTM D6124-01.
- Biocompatibility (skin irritation and sensitization) results are based on standardized biological testing protocols.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the computational sense. The "training" would be analogous to the manufacturing process adhering to quality controls.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no "training set" for a physical device in the context of an AI algorithm. The manufacturing process is designed to produce gloves that inherently meet the established performance standards.
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NOV 2 2 2005
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:
Mr. John Lai Shanghai Antares industries inc. No. 259 yushu Road Cangqiao Township Songjiang County, Shanghai China, P.R.C.
Date Summary Prepared: August 15, 2005
2. Name of the Device:
Shanghai Antares Industries, inc. Disposable Powder Free Vinyl Synthetic Exam Gloves, With Vitamin Complex, Nopal and Lanolin (Blur Color)
3. Predicate Device Information:
EST International Corporation
Opus-E Disposable Powder Free Vinyl Synthetic Exam Gloves With Vitamin Complex, Nopal and Lanolin (Yellow Gold),K040108.
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 D5250-00E4.
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:
Shanghai Antares Industries,Inc. whose Disposable Powder Free Vinyl Synthetic Exam Gloves, With Vitamin Complex, Nopal and lanolin (Blue Color) is substantially equivalent to the device manufactured by EST International Corporation (K040108) except for the blue color additive being added to this glove.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Ever Global Enterprise Corporation's glove production are Based on ASTM D5250-00E4. 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-5151-99 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 D6124-01 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:
Shanghai Antares Industries Inc. whose Disposable Powder Free Vinyl Synthetic Exam Gloves, With Vitamin Complex, Nopal and Lanolin Blue Color conform fully to ASTM D-5250-00E4 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"
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2005
Mr. John Lai Manager Shanghai Antares Industries, Incorporated No. 259 Yushu Road, Cangqiao Township Songjiang County, Shanghai CHINA, P.R.C.
Re: K052612
Trade/Device Name: Disposable Powder Free Vinyl Synthetic Exam Gloves, With Vitamin Complex, Nopal and Lanolin (Blue Color) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 8, 2005 Received: November 16, 2005
Dear Mr. Lai:
. '
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 - Mr. Lai
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sujata y. Michai Oms.
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
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Applicant: Shanghai Antares Industries, Inc.
510(k) Number (if known):
Device Name: Disposable Powder Free Vinyl Synthetic Exam Gloves, With
Vitamin Complex, Nopal and Lanolin (Blue 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.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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 CC
Shula M. Murphy, MD 11/21/05
Division Sign-Off)
Division of Anesthesiology, General Hospital
ology. General Hosnitz
510(K) Number: K052412
§ 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.