(26 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 a purpose 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, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4.
This submission is for a Class I medical device, "Grand Work Plastics Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves—Powdered," which is a disposable patient examination glove. As such, the acceptance criteria and supporting studies are focused on performance characteristics relevant to patient examination gloves, rather than those for complex diagnostic algorithms.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D5250-00E4 (General) | Meets all requirements |
| ASTM D5250-00E4 (Physical and Dimensions Testing) | Meets requirements (Inspection Level S-2, AQL 4.0) |
| ASTM D5151-99 (FDA 1000 ml. Water Fill Test for pinholes) | Meets requirements (AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| ASTM D6124-01 (Residual Powder Test for Starch) | Meets (contains no more than 10 mg/dm²) in accordance with "powdered" claims |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. Instead, it refers to "Inspection Level S-2, AQL 4.0" for physical and dimensions testing, and "AQL 2.5, Inspection Level I" for the water fill test. These are sampling plans from the referenced ASTM standards, which define how many units are tested from a lot to determine acceptance.
The data provenance is not specified in terms of country of origin, but the testing was performed by the manufacturer, Grand Work Plastics Products Co., Ltd., which is located in Zanhuang, Hebei Province, P.R. China. The studies are non-clinical (laboratory/bench testing), not involving human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device. The "ground truth" for patient examination gloves is established by the specified ASTM standards and FDA guidelines, which define measurable physical and chemical properties and their acceptable limits. Expert consensus as typically understood for diagnostic algorithms (e.g., radiologists interpreting images) is not used here.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for subjective diagnostic interpretations in the context of clinical studies involving multiple human readers. This is not relevant for the objective, standardized non-clinical tests performed on patient examination gloves. The tests involve direct measurement and adherence to predefined criteria.
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 involves comparing the diagnostic performance of multiple human readers, often with and without AI assistance, on a set of cases. This is completely irrelevant for a patient examination glove.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
While the term "standalone study" usually refers to the performance of an AI algorithm without human intervention, if we interpret it generally as the device's inherent performance without human human-in-the-loop interaction, then yes, the tests described (physical, dimensions, water fill, skin irritation, sensitization, residual powder) assess the standalone performance of the glove itself against established standards. There is no "algorithm" involved.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established industry standards and regulatory requirements. Specifically:
- ASTM Standard D5250-00E4: Standard Specification for Poly(vinyl chloride) Patient Examination Gloves.
- ASTM Standard D5151-99: Standard Test Method for Detection of Pinholes in Medical Gloves.
- ASTM D6124-01: Standard Test Method for Residual Powder on Medical Gloves.
- Biocompatibility standards: For primary skin irritation and sensitization.
These standards define the acceptable range or absence of certain characteristics (e.g., tensile strength, elongation, freedom from holes, absence of irritation).
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train a machine learning algorithm. This device is a physical product, not an AI algorithm, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for a physical patient examination glove.
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JUN - 1 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: _| (04 1188
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—Powdered
3. Predicate Device Information:
Shijiazhuang Great Vision Plastic Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves (K992554)
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, 80L YZ, 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 Vinyl Patient Examination Gloves-Powdered, is substantially equivalent in safety and effectiveness to the Shijiazhuang Vision Plastic Products Co., Ltd. Synthetic Powdered 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 "powdered' claims (contain no more thon 10 mg/dm2).
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Grand Work Plastics Co., Ltd. Synthetic Vinyl Patient Examination gloves-Powdered 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
JUN - 1 2004
Grand Work Plastics Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 W. Central Avenue, #D Brea, California 92821
Re: K041188
Trade/Device Name: Grand Work Plastics Products Company Limited Synthetic Vinyl Patient Examination Glove--Powdered Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 5, 2004 Received: May 6, 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 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 (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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Attachment A
Page 1 of 1
(IF KNOWN) : _ K 0 4 ) | 1 8 8 = 510(k) NUMBER Grand Work Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic Vinyl Patient Examination Gloves--Powdered
A patient examination glove is disposable device intended for medical a purpose 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)
Ke Muley
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K041188
§ 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.