(66 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 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, Powdered Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Grand Work Plastics Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves—Powdered:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Physical Properties | ASTM-D-5250-00E4 Standard (Physical and Dimensions Testing) | All testing meets requirements (Inspection Level S-2, AOL 4.0). |
| Barrier Integrity | FDA 1000 ml. Water Fill Test (based on ASTM D-5151-99) | Samplings met requirements (AQL 2.5, Inspection Level I). |
| Biocompatibility | Primary Skin irritation testing | No primary skin irritant reactions shown. |
| Biocompatibility | Skin Sensitization (allergic contact dermatitis) testing | No sensitization reactions shown. |
| Powder Content | Residual Powder Test (based on ASTM D6124-01 for Starch) | Conforms to "powdered" claims (contain no more than 10 mg/dm2). |
| Overall Conformance | ASTM-D-5250-00E4 Standard | Conforms fully. |
| Overall Conformance | Applicable 21 CFR references | Conforms fully. |
| Overall Conformance | Pinhole FDA requirements | Meets requirements. |
| Overall Conformance | Biocompatibility requirements | Meets requirements. |
| Overall Conformance | Labeling claims | Meets claims. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions sample sizes and inspection levels where applicable:
- Physical and Dimensions Testing (ASTM-D-5250-00E4): Inspection Level S-2. AQL 4.0.
- FDA 1000 ml. Water Fill Test (ASTM D-5151-99): Samplings of AQL 2.5, Inspection Level I.
Provenance: The tests were conducted by the manufacturer, Grand Work Plastics Products Co., Ltd., in China, as part of their production and quality control processes to ensure compliance with ASTM standards. The data is retrospective, as it relates to the evaluation of the device against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for these tests is established by published, internationally recognized consensus standards (ASTM and FDA test methods), not by individual expert interpretation of complex clinical cases or images. The "experts" would be the technical committees that develop and validate these standards.
4. Adjudication Method for the Test Set
Not applicable. As the tests involve objective measurements against predefined acceptance criteria from standards (e.g., AQL levels for physical properties and water fill tests, quantitative limits for residual powder, and observable skin reactions for biocompatibility), there is no need for a subjective adjudication method like 2+1 or 3+1. The results are compared directly to the specified benchmarks.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where the performance involves human interpretation of results, often with AI assistance. For patient examination gloves, the performance evaluation is based on objective physical, chemical, and biological tests, not reader-dependent assessments.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a way, the entire testing regimen described can be considered "standalone" as it evaluates the inherent properties of the gloves themselves without human interaction during the functional assessment. The tests are designed to measure the intrinsic characteristics and performance of the glove material and construction. There is no "algorithm" in the context of AI, but the manufacturing and testing processes are designed to produce a standalone product meeting specifications.
7. The Type of Ground Truth Used
The ground truth used is primarily based on:
- Consensus Standards: Specifically, ASTM Standard D5250-00E4 for physical properties and dimensions, ASTM D-5151-99 for water leak testing, and ASTM D6124-01 for residual powder content.
- Regulatory Requirements: FDA requirements for pinhole integrity and general biocompatibility.
- Observation/Measurement: Direct observation for skin irritation and sensitization.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (patient examination gloves), not a machine learning or AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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 8807.92.
| The assigned 510(k) number is: | K041225 |
|---|---|
| -------------------------------- | --------- |
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 (Yellow) Vinyl Patient Examination Gloves—Powdered
3. Predicate Device Information:
Shijiazhuang Great Vision Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves (Yellow) (K992862)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powdered 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 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 (Yellow) Vinyl Patient Examination Gloves-Powdered, is substantially equivalent in safety and effectiveness to the Shijiazhuang Vision Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves (Yellow).
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. AOL 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 "powdered' claims (contain no more than 10 mg/dm2).
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Grand Work Plastics Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination gloves---- Powdered conform fully to ASTM-D-5250-00 €4 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 is a black and white logo. The logo is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2004
Grand Work Plastics Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Brea, California 92821
Re: K041225
Trade/Device Name: Synthetic (Yellow) Vinyl Patient Examination Gloves --- Powdered Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 5, 2004 Received: May 10, 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.
Susan Runne
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): K041225
Device Name: __ Synthetic (Yellow) Vinyl Patient Examination Gloves--Powdered
Indications For 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ × (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))
K. Kelley
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K041225
§ 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.