(33 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, 801.YZ, and mects all requirements of ASTM Standard D5250-00 4.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves:
Device: Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Plasticizer EBN&BET
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: (Based on ASTM D5250-00 4) | Meets requirements. Inspection Level S-2, AQL 4.0. |
| Freedom from Holes (FDA 1000ml. Water Fill Test): (Based on ASTM D5151-99) | 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 (for "Powder Free" claim): (Based on ASTM D6124-01 for Starch) | Meets "Powder Free" claims (contains no more than 2mg powder per glove). |
| Biocompatibility Requirements: | Meets requirements (implied by no skin irritation/sensitization and overall conclusion). |
| Labeling Claims (General): | No special labeling claims (e.g., hypoallergenic). |
2. Sample size used for the test set and the data provenance:
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Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific sample size not provided, but AQL 4.0 implies a statistically determined sample based on lot size).
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Freedom from Holes (Water Fill Test): Samplings of AQL 2.5, Inspection Level I. (Specific sample size not provided, but AQL 2.5 implies a statistically determined sample based on lot size).
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Primary Skin Irritation and Skin Sensitization: The text does not specify the sample size for these tests.
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Residual Powder Test: Not specified.
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Data Provenance: The tests were performed by the manufacturer, Grand Work Plastics Products Co., Ltd., presumably in P.R. China, where the company is located. The tests are "Non-Clinical tests," implying they were conducted in a laboratory or similar controlled environment. The data is retrospective in the sense that it was generated for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a Class I medical device (patient examination glove) and the testing described is primarily laboratory-based performance testing and biocompatibility.
- No human experts were used to establish ground truth in the context of clinical interpretation or diagnosis. The ground truth for these tests is based on objective measurements against established ASTM standards and FDA requirements (e.g., water leak test, dimensional measurements, chemical analysis for powder, and animal/in vitro biocompatibility tests for skin irritation/sensitization).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving reader interpretation (e.g., radiology AI). This submission concerns a physical medical device and its performance against technical specifications and biocompatibility, not diagnostic accuracy requiring human reader adjudication. The results are objective measurements.
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. This type of study (MRMC comparative effectiveness) is not applicable to an examination glove. It is primarily used for diagnostic devices, especially those incorporating AI, where human readers interpret medical images or data. The device in question is a physical barrier intended for infection control.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or AI-based system. It is a physical product.
7. The type of ground truth used:
- Objective measurements against established standards and laboratory test results.
- For physical and dimensional testing: ASTM D5250-00 4.
- For freedom from holes: FDA 1000ml. Water Fill Test based on ASTM D5151-99.
- For biocompatibility (skin irritation and sensitization): Laboratory test results (the specific methods like ISO standards for biocompatibility are not explicitly cited but are implied by the "no primary skin irritant or sensitization reactions" statement).
- For residual powder: ASTM D6124-01.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this product, as it is not an AI/machine learning device. The testing described focuses on product quality control and performance verification against established standards for manufacturing.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for one.
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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: _K_O5 | 14
Submitter's Identification: 1.
Mr. Shuangzhu Ma Grand Work Plastics Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China
Date Summary Prepared: April 13, 2005.
2. Name of the Device:
Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Plasticizer EBN&BET
Predicate Device Information: 3.
Shijiazhuang Junfei Plastic Products Co., Ltd. Powder Free Synthetic Vinyl Patient Examination Gloves (K010627)
Device Description: 4.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder Free Vinyl Patient Examination Glove, 801.YZ, and mects 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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EXHIBIT#1 Page 2 of 2
Comparison to Predicate Devices: 6.
Grand Work Plastic Products Co., Ltd.'s Powder Free Vinyl Synthetic Examination Gloves with Plasticizer EBN&BET is substantially cquivalent in safety and effectiveness to the Shijiazhuang Junfci Plastic Products Co., Ltd.'s Powder Free Synthetic 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 D5250-00 4. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL4.0.
The FDA 1000ml. Water Fill Test based on ASTM D5151-99 was also conducted with samplings of AQL2.5, 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 2mg powder per glove).
Discussion of Clinical Tests Performed: 8.
Not Applicable -----There is no Hypoallergenic Claim.
9. Conclusions:
Grand Work Plastic Products Co., Ltd.'s Powder Free Vinyl Synthetic Examination Gloves with Plasticizer FBN&BET conform fully to ASTM D5250-00 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" product cited.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Micky Lin Official Correspondent Grand Work Plastics Products Company Limited 3973 Schafer Avenue Chino, California 91710
Re: K051166
Koo IToo
Trade/Device Name: Powder Free Vinyl Synthetic Examination Gloves with Plasticizer EBN&BET Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 11, 2005 Received: May 5, 2005
Dear Mr. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we flave reviewed your securer some 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 Incersate conmisered prior to reasified in accordance with the provisions of Amendinons, or to are 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 approval uppression (11-14). The general controls provisions of the Act include controls providents or 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 If your device is crabbect to such additional controls. Existing major regulations affecting (1 MA), it may of subject to back address and Regulations, Title 21, Parts 800 to 898. In your device can oo found in the bear nouncements concerning your device in the Federal Register.
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Page 2 - Mr. Lin
Please be advised that FDA's issuance of a substantial equivalence determination does not Freast be auvrssed that 127 to levels as that your device complies with other requirements mean that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of any I ouchar based is requirements, including, but not limited to: registration r ou intist compry with a 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 OF Revelopments (QS) regulation (21 CFR Part 820); and if requirence as set form in are quadiation 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) This letter will and A you to organ finding of substantial equivalence of your device to a premarket notification. - The Pice 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), 11 you donto 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 may obtain other gelecters, 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,
Jurette G. M, chiro, m.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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Attachment A
INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN): _ KO51164
- APPLICANT: DEVICE NAME:
Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Plasticizer EBN&BET
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purposes that is worn on the cxaminer'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)
§ 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.