(30 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.
The Vinyl Plastic Co-Polymer Powder-Free Examination Gloves (Blue Color) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00a1 and ASTM D-5250.
The provided document describes the safety and effectiveness information for the "Grand Work Plastic Products Co., Ltd. Vinyl Nitrile Co-Polymer Powder Free Exam Gloves (Blue Color)".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing | Meets requirements of ASTM D-6319-00a1 and ASTM D-5250 (Inspection level S-2, AQL 4.0) | Meets requirements of ASTM D-6319-00a1 and ASTM D-5250 (All testing meets requirements) |
| Pinhole (Water Fill Test) | Meets requirements of FDA 1000 ml. Water Fill Test based on ASTM D-5151-99 (AQL 2.5, inspection level G-1) | Meets requirements of FDA 1000 ml. Water Fill Test based on ASTM D-5151-99 (Met requirements) |
| Primary Skin Irritation | No primary skin irritant reactions | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions | No sensitization reactions |
| Residual Powder | No more than 2 mg powder per glove (based on ASTM D-6124-01 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
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact sample size is not explicitly stated but is determined by the AQL and inspection level standards.
- Pinhole (Water Fill Test): Inspection level G-1, AQL 2.5. The exact sample size is not explicitly stated but is determined by the AQL and inspection level standards.
- Primary Skin Irritation and Skin Sensitization: Sample size not specified.
- Residual Powder Test: Sample size not specified.
- Data Provenance: Not explicitly stated, however, the submitter is based in China, suggesting the testing likely occurred in China or at an approved testing facility. The data is reported as part of a premarket notification (510(k)), representing retrospective data collected for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The tests performed are objective, laboratory-based tests (e.g., physical measurements, chemical analysis, biocompatibility assays) that do not require human expert interpretation to establish ground truth in the way medical imaging or clinical diagnoses would. The "ground truth" is established by the results of the standardized tests themselves against predefined criteria.
4. Adjudication method for the test set
- Not applicable. As noted above, the tests are objective and do not involve human interpretation that would necessitate adjudication. The results are compared directly to the specified ASTM standards and thresholds.
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 glove) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (examination glove) and not an algorithm or AI system.
7. The type of ground truth used
- Objective measurements against established standards: The ground truth for this device is based on objective laboratory measurements and tests conforming to recognized industry standards (ASTM D-6319-00a1, ASTM D-5250, ASTM D-5151-99, ASTM D-6124-01) and regulatory requirements (FDA 1000 ml. Water Fill Test, biocompatibility guidelines for primary skin irritation and sensitization). The "ground truth" is whether the physical, chemical, and biological properties of the gloves meet these predefined quantitative criteria.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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K 051662
JUL 2 2 2005
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: _ _____________________________________________________________________________________________________________________________________________
1. Submitter's Identification:
Mr. Shuangzu Ma Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China
Date Summary Prepared: June 16, 2005
2. Name of the Device:
Grand Work Plastic Products Co., Ltd. Vinyl Nitrile Co-Polymer Powder Free Exam Gloves (Blue Color)
3. Predicate Device Information:
Shijiazhuang Eversharp Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Examination Gloves (K011882)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Glove, 80 LZA, and meets all
requirements of ASTM standard D-6319-00a1 and ASTM D-5250.
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 Plastic Products Co., Ltd.'s Vinyl Nitrile Co-Polymer Powder Free Exam Gloves (Blue Color) is substantially equivalent in safety and effectiveness to the Shijiazhuang Eversharp Plastic Products Co., Ltd.'s Synthetic Powder Free (Yellow) Vinyl Examination Glvoes.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Grand Work Plastic Products Co., Ltd.'s glove product are
bassed on ASTM-D-6319-00a1 and ASTM D-5250. 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 G-1, 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 D-6124-01 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 Plastic Products Co., Ltd.'s Vinvl Nitrile Co-Polymer Powder Free Exam Gloves (Blue Color) conform fully to ASTM D-6319-00a1 and ASTM D-5250 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 and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
JUL 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Grand Work Plastic Products, Company, Limited c/o Mr. Micky Lin Gloveco Incorporated 3973 Schafer Avenue Chino, California 91710
Re: K051662
Trade/Device Name: Vinyl Nitrile Co-Polymer Powder Free Examination Gloves (Blue Color) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 13, 2005 Received: July 14, 2005
Dear Mr. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner co may to ria) 2011-12-11 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 I ou mayy are expressions 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to back adderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the overning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised mat TDA s issualled of a business with other requirements of the Act that FDA has made a determination that Jour securities of by other Federal agencies. You must of any Federal statutes and regulations annuments, but not limited to: registration and listing (21 comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (bections over device as described in your Section 510(k) i his letter will anow you to oegin manceing your are a convalence of your device to a legally premarket nothication. The PDA inding of backantal or 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 If you desire specific advice for your do not as a loss, please note the regulation entitled, and Colliact the Office of Comphalled as (21) = 17 = 15 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = 1 " Misbranding by Icierchec to premance no ilities under the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-204 or Minutaturers, International and Oct.ss http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Soutie y. Michie Omd.
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 kn wn):_K051662
$
Device Name: Vinyl `itrile Co-Polymer Powder-Free Examination Gloves (Blue Color)
Indications For Use The Vinyl Plastic Co-Polymer Powder-Free Examination Gloves (Blues Indications For Use The Viny Flasto Co Fermer over that is worn on the examiner's hands Color) is a disposuore normination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subp: D) AND/OR
Over-The-Counter Use ___ × (21 CFR 801 Subpart C)
(PLEASE DO NOT VRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Murphry, Ph.D. 2/2/05
ivision Sign-Off) ivision of Anesthesinlogy. General Hospital, Infontion Control, Dental Devices
K051LL2
§ 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.