(35 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 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 I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00€4.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Performance Metric | Reported Device Performance |
|---|---|---|
| ASTM D5250-00€4 (General) | All requirements | Meets all requirements of ASTM Standard D5250-00€4 |
| FDA 1000 ml. Water Fill Test based on ASTM D-5151-99 | AQL | Meets requirements at AQL 2.5, Inspection Level I |
| Biocompatibility (Primary Skin Irritation) | Irritation | No primary skin irritant reactions |
| Biocompatibility (Skin Sensitization) | Sensitization | No sensitization reactions |
| Powder-free Claim (ASTM D6124-01 for Starch) | Residual Powder | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
2. Sample Size Used for the Test Set and Data Provenance
The document specifies the following for the non-clinical tests:
- ASTM D5250-00€4 (Physical and Dimensions Testing): Inspection Level S-2, AQL 4.0. The exact sample size is not explicitly stated but is implicitly defined by the AQL (Acceptable Quality Level) and inspection level, which are statistical sampling plans.
- FDA 1000 ml. Water Fill Test based on ASTM D-5151-99: AQL 2.5, Inspection Level I. Again, the exact sample size is not explicitly stated but is defined by the AQL and inspection level.
- Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biocompatibility tests is not provided in the document.
- Residual Powder Test: The sample size for this test is not provided.
Data Provenance: The tests were conducted by Grand Work Plastics Products Co., Ltd. in China. The data's provenance is therefore retrospective (tests conducted on manufactured products) and originates from China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical medical glove, and the "ground truth" for its performance is established through objective, standardized physical and chemical tests, not through expert human interpretation of data for diagnostic purposes.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as #3. The tests have predefined pass/fail criteria based on accepted standards.
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 AI devices where human readers interpret medical images or data. The device in question is a physical glove, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study (in the context of an algorithm) was not done. This device is not an algorithm or AI product. Its performance is measured through direct laboratory testing.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Objective, Pre-defined Standards and Specifications: Specifically, ASTM D5250-00€4, ASTM D-5151-99, and ASTM D6124-01. These standards define the acceptable physical properties, barrier integrity (pinhole), and powder content.
- Biocompatibility Testing Protocols: Which assess the biological response to the material.
8. The Sample Size for the Training Set
This refers to the sample size of data used to train a machine learning model. Since the device is a physical product and not an AI/ML algorithm, a "training set" in this context is not applicable. The manufacturing process for the gloves would involve quality control and process validation, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm associated with this device, this question is not applicable.
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NOV 1 7 2004
Image /page/0/Picture/1 description: The image shows the text "K042830" in a handwritten style, followed by the text "510(K) SUMMARY" in a more formal font. The text "510(K) SUMMARY" is underlined. The image appears to be a document or label with a reference number and a summary title.
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. Shuangzu Ma Grand Work Plastics Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China
Date Summary Prepared: October 01, 2004
2. Name of the Device:
Grand Work Plastics Products Co., Ltd.
Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color
3. Predicate Device Information:
Shanghai PM Plastic s Enterprise Co., Ltd.
Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color (K024026)
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, 80LYZ, 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. Powder Free Vinyl Synthetic Examination Gloves with Aloc Vera, Green Color is substantially equivalent in safety and effectiveness to the Shanghai PM Plastics Enterprise Co., Ltd. Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color.
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-5250-00€44. 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. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color 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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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 featuring three curved lines that resemble a human figure or a stylized representation of a flag.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 2004
Grand Work Plastic Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 W. Central Avenue, # D Brea, California 92821
Re: K042830
Trade/Device Name: Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 1, 2004 Received: November 3, 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. V rue ret 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/dsma/dsmamain.html
Sincerely yours.
Chiu Lin, Ph.D.
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): K042830 APPLICANT: DEVICE NAME:
Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Clu L
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infaction Control, Dental Devices
510(k) Number. L-042830
§ 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.