(134 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00e4.
This 510(k) summary describes a patient examination glove and its performance testing. It focuses on demonstrating substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria in the context of an AI/software device. Therefore, many of the requested fields are not applicable to this document.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM D5250-00E4) | Meets requirements (Inspection Level S-2, AQL 4.0) |
| Pinhole requirements (FDA 1000 ml. Water Fill Test, ASTM D-5151-99) | Meets requirements (samplings of AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| Residual Powder Test (ASTM D6124-01 for Starch) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Physical and Dimensions Testing: Not explicitly stated, but performed with "Inspection Level S-2, AQL 4.0".
- Pinhole (Water Fill Test): Not explicitly stated, but performed with "samplings of AQL 2.5, Inspection Level I".
- Primary Skin Irritation and Skin Sensitization: Not explicitly stated.
- Residual Powder Test: Not explicitly stated, but performed at "finished inspection".
- Data Provenance: Not specified, but likely from internal manufacturing and testing processes of Grand Work Plastics Products Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical device (gloves), not an AI/software device where ground truth is established by experts. The performance is measured against physical and chemical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described for this type of device testing.
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 for a physical medical device (gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device (gloves), there is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by conformance to established industry standards (ASTM D5250-00E4, ASTM D-5151-99, ASTM D6124-01) and biocompatibility testing (Primary Skin Irritation and Skin Sensitization).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. The "training" for a manufacturing process would be the ongoing quality control and process validation, which is not detailed in terms of sample size for this summary.
9. How the ground truth for the training set was established
Not applicable. There is no training set in the context of AI/ML for this device. The manufacturing process implicitly aims to produce gloves that meet the defined standards.
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JUL 28 2004
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: K040682
1. Submitter's Identification:
Mr. Shuangzu Ma Grand Work Plastics Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China
Date Summary Prepared: March 01, 2004
2. Name of the Device:
Grand Work Plastics Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves-Powder Free
3. Predicate Device Information:
Shijiazhuang Great Vision Plastic Products Co., Ltd. Synthetic Powder Free Vinyl Patient Examination Gloves (K992555)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00€4.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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6. Comparison to Predicate Devices:
Grand Work Plastics Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves-Powder Free, is substantially equivalent in safety and effectiveness to the Shijiazhuang Vision Plastic Products Co., Ltd. Synthetic Powder Free Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Grand Work Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00E4. 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 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 glove).
8. Discussion of Clinical Tests Performed:
Not Applicable -- There is no hypoallergenic Claim.
9. Conclusions:
Grand Work Plastics Co., Ltd. Synthetic (White) Vinyl Patient Examination gloves— Powder Free conform fully to ASTM-D-5250-00E4 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.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 28 2004
Grand Work Plastic Products Company Limited C/O Mr. James Chu GLOVECO, Incorporated 590 West Central Avenue #D Brea, California 92821
Re: K040682
Trade/Device Name: Synthetic Vinyl Patient Examination Gloves-Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 18, 2004 Received: May 24, 2004
Dear Mr. Chu:
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. Chu
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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Grand Work Plastics Products Co., Ltd. Device Name:_ Synthetic Vinyl Patient Examination Gloves - Powder-Free ______________________________________________________________________________________________________________________________________________________________________________
Indications For Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ﮯ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rolen Marley
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: 040682
§ 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.