(203 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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
This document describes the acceptance criteria and the study conducted for the Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through its conformance to established standards and tests for examination gloves.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Conformance to ASTM D5250-92, Inspection Level S-2, AQL 4.0 | All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2. AOL 4.0. |
| Pinhole / Water Leak Test: Conformance to FDA 1000 ml. Water Fill Test, sampling AQL 2.5, Inspection Level S-4 | The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. |
| Primary Skin Irritation: No significant primary skin irritant reactions | Testing conducted with results showing no primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis): No significant sensitization reactions | Testing conducted with results showing no sensitization reactions. |
| Powder-Free Claim: Absence of starch as per USP Iodine Test | A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims. We adhere to all USP Iodine test methodology and testing conducted revealed passing results. |
| Biocompatibility: No adverse reactions (based on irritation and sensitization tests) | Biocompatibility requirements met as shown by data in Section 7 (Primary Skin irritation and Skin Sensitization testing). |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size:
- For Physical and Dimensions Testing: Inspection Level S-2.
- For FDA 1000 ml. Water Fill Test: Sampling AQL 2.5, Inspection Level S-4.
- For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but standard biocompatibility testing involves a statistically relevant number of subjects/samples.
- For USP Iodine Test: Routinely performed at finished inspection; specific sample size per batch not provided.
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Data Provenance: The studies were conducted by the device manufacturer, Shijiazhuang Hongxiang Plastics Products Co., Ltd., based in P.R. China. The studies are retrospective relative to the submission date, as they were performed to demonstrate compliance of existing product batches.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is a medical glove, and the "ground truth" for its performance is established by objective, standardized laboratory and materials testing, not by expert interpretation of medical images or conditions. Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The "experts" involved would be qualified laboratory technicians and material scientists who conduct the tests according to published ASTM and FDA standards. Specific numbers or qualifications of these individuals are not provided in the summary.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic assessments, particularly in imaging studies. For this device, the tests are primarily objective measurements against predefined thresholds set by ASTM standards and FDA guidelines (e.g., AQL levels for pinholes, pass/fail for irritation). Therefore, an adjudication method for conflicting expert opinions is not applicable. The results are quantitative or clearly pass/fail.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images), and the AI's effect on human performance is being evaluated. This device is an examination glove, which does not involve human interpretation in the same way.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The document describes several tests performed directly on the device (the gloves) to demonstrate its intrinsic properties and compliance with standards, independent of human interaction for interpretation purposes. These include:
- Physical and Dimensions Testing against ASTM D5250-92.
- FDA 1000 ml. Water Fill Test (for pinholes).
- Primary Skin Irritation testing.
- Skin Sensitization testing.
- USP Iodine Test for starch.
7. Type of Ground Truth Used
The ground truth used is primarily objective performance metrics and compliance with established industry standards and regulatory requirements. This includes:
- ASTM Standard D5250-92: For physical properties and dimensions.
- FDA 1000 ml. Water Fill Test requirements: For pinhole integrity.
- Biocompatibility guidelines: For primary skin irritation and sensitization.
- USP Iodine Test methodology: For confirming "powder-free" claims.
These are well-defined, quantitative, or qualitative pass/fail criteria, rather than subjective expert consensus or pathology interpreted from patients.
8. Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. This device is a physical product (medical glove) and does not employ an AI algorithm or machine learning. Therefore, there is no training set in the context of AI development. The "training" for the manufacturing process involves adherence to Good Manufacturing Practices (GMP) and quality control, but not a data-driven training set for an AI model.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, there is no training set for an AI algorithm. The manufacturing process and quality control for the gloves are based on established manufacturing specifications, material science principles, and quality assurance protocols that ensure the product consistently meets the performance standards outlined in Section 7.
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510(K) SUMMARY K 992821
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. Guixi Liu Shijiazhuang Hongxiang Plastics Products Co., Ltd. Lu Quan City, New High technologies Industrial Zone Shijiazhuang, Hebei Province 050200 P.R. China
Date Summary Prepared: July 29, 1999
2. Name of the Device:
Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves
3. Predicate Device Information:
Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#964964 Cheer & Merit Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#942042
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, 80LYZ, and meets all requirements of ASTM Standard D5250-92.
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:
Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves and the Cheer & Merit Powder-Free Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Shijiazhuang Hongxiang Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-92. 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 was also conducted with samplings of AQL 2.5, Inspection Level S-4, 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 USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims. We adhere to all USP Iodine test methodogy and testing conducted revealed passing results.
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Shijiazhuang Hongxiang Plastics Co., Ltd. Synthetic Vinyl Patient Examination gloves (Powder-Free) conform fully to ASTM-D-5250-92 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
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MAR 1 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shijiazhuang Hongxiang Plastics Products Co., Ltd. C/O Basic Medical Industries, Inc. James Chu 12390 East End Avenue Chino, California 91710
Re : K992821 Synthetic Powder-Free Vinyl Patient Trade Name: Examination Gloves Requlatory Class: I Product Code: LYZ Dated: February 28, 2000 Received: March 2, 2000
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 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 The qeneral controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Chu
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
510(k) NUMBER (IF KNOWN) :_ Shijiazhuang Hongxiang Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic Powder Free Vinyl Patient Examination Gloves-Powder Free
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.
(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 X(Optional Format 1-2-96) |
| Qius. Lim | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control,and General Hospital Devices | |
| 510(k) Number | K992821 |
§ 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.