(29 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 10 ween 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, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-00.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document describes a 510(k) submission for patient examination gloves, which are low-risk devices. Therefore, the "study" described is primarily a series of non-clinical bench tests and biocompatibility assessments demonstrating equivalence to a predicate device, rather than a clinical trial involving human patients or complex AI algorithms.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (based on ASTM-D-5250-00) | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. |
| Pinhole Requirement (FDA 1000 ml. Water Fill Test) | Conducted with samplings of AQL 2.5, Inspection Level I, meeting requirements. |
| Biocompatibility (Primary Skin Irritation and Skin Sensitization) | Results showing no primary skin irritant or sensitization reactions. |
| Labeling Claims | No special labeling claims; does not claim gloves as hypoallergenic. |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (The exact sample size isn't explicitly stated but is determined by the AQL and inspection level from ASTM-D-5250-00, which are standard statistical sampling plans.)
- Pinhole Test (FDA 1000 ml. Water Fill Test): "AQL 2.5, Inspection Level I" (Similar to above, sample size is determined by AQL and inspection level from standard testing protocols.)
- Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but these are typically performed on a limited number of animal or human subjects/patches under controlled lab conditions.
- Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Eversharp Plastics Products Co., Ltd., in Hebei Province, P.R. China. The data would be prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for this type of device. The "ground truth" for glove performance is established by standardized test methods (ASTM standards, FDA water fill test) and the results are analytical measurements, not subjective interpretations by experts.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements against predefined thresholds, not subjective assessments requiring adjudication.
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 device is a physical medical product (gloves) and does not involve AI or human readers for diagnostic interpretation.
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 software.
7. The Type of Ground Truth Used
The ground truth used for these tests were:
- Standardized Thresholds: Defined by ASTM-D-5250-00 for physical properties and dimensions, and by FDA requirements for the pinhole test.
- Biocompatibility Standards: Established limits and criteria for irritation and sensitization reactions based on recognized testing protocols.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI or machine learning model.
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JUL 1 7 2001
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in This Sunmillary of STO(1) Bases of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: _ KOll 1884
1. Submitter's Identification:
Mr. Yinhai Wang Shijiazhuang Eversharp Plastics Products Co., Ltd. No. 312 East Long Quan Road Luquan, Hebei Province P.R. China
Date Summary Prepared: May 11, 2001
2. Name of the Device:
Shijiazhuang Eversharp Plastics Products Co., Ltd. Powdered Synthetic Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves K#983645
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, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-00.
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 10 ween healthcare personnel and the patient's body, fluids, waste or environment.
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6. Comparison to Predicate Devices:
Shijiazhuang Eversharp Plastics Products Co., Ltd. Powdered Synthetic Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle 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 Shijiazhuang Eversharp Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00. 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 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.
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Shijiazhuang Eversharp Plastics Co., Ltd. Powdered Synthetic Vinyl Patient Examination gloves conform fully to ASTM-D-5250-00 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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine, but in this case, it is a more abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2001
Shijiazhuang Eversharp Plastic Products Co., Ltd. C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 12390 East End Avenue 91710 Chino, California
Re : K011884 Powdered Synthetic Vinyl Patient Trade/Device Name: Examination Gloves Requlation Number: 880.6250 Requlatory Class: I Product Code: LYZ May 18, 2001 Dated: Received: June 18, 2001
Dear Mr. Chu:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory
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Page 2 - Mr. Chu
In addition, FDA may publish further announcements action. action. In addression in the Federal Register. Please note: concerning your device in the sunce if cation submission does chis response to your premasure to might have under sections 531 not arrect any obligation of indevices under the Electronic Chrough 542 or the Act 101 xovisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis recei will arrow your market notification. The FDA described in your 510\x) promise of your device to a legally Finding of Subbeaneral Squresults in a classification for your marketed predicate actes your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirit advacultionally 809.10 for in for in for in sitro regulation (21 crk rare over and addition of Compliand advertisi additionally, for questions on the promotion and advertisit 594-4692. 594-482. Addicionariy, for quebelone of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other qeneral reference to premarket hoeffication under the Act may be obtained fri Illormation of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address (800) - 350 - 2012a - gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Kj. Clitatord
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment A
Page 1 of 1
RO11884 510(k) NUMBER (IF KNOWN) : _ Shijiazhuang Eversharp Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Powdered Synthetic Vinyl Patient Examination Gloves
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.
Clair S. Ulm
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices E1 O(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96)
§ 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.