(105 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 a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
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 requirement of ASTM Standard D5250-00.
The provided text describes a 510(k) submission for "Tangshan Zhongying Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free". This submission focuses on medical device regulatory clearance based on substantial equivalence, rather than a clinical study evaluating AI algorithms. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, AI effect size) is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance related to the physical and biological characteristics of the gloves.
Here's the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Description | Reported Device Performance |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5250-00 Compliance | The gloves must meet all requirements of ASTM Standard D5250-00, which specifies requirements for polyvinyl chloride patient examination gloves. This standard includes various physical property tests (e.g., tensile strength, elongation at break), dimensions, and freedom from holes. | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves." and "conform fully to ASTM-D-5250-00 standard" |
| Physical and Dimensions Testing | Based on ASTM-D-5250-00 standard, with Inspection Level S-2, AQL 2.5. This implies specific sampling plans and acceptable quality limits for defects. | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2. AOL 2.5." |
| Freedom from Holes (Pinhole FDA Requirements) | Assessed using the FDA 1000 ml. Water Fill Test. The acceptance criteria for this test specify a maximum acceptable quality level (AQL) for pinholes. | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements" and "meets pinhole FDA requirements." |
| Primary Skin Irritation | The objective is to ensure the gloves do not cause significant skin irritation. | "Primary Skin irritation...testing was conducted with results showing no primary skin irritant or sensitization reactions." |
| Skin Sensitization (Allergic Contact Dermatitis) | The objective is to ensure the gloves do not cause allergic reactions or sensitization. | "Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions." |
| Powder-Free Claim | The gloves must contain no more than 2 mg powder per glove to meet the "powder-free" claim. | "testing...is conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)." |
| Biocompatibility | General biocompatibility requirements. | "meets...biocompatibility requirements" |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "samplings of AOL 2.5, Inspection Level I" for the Water Fill Test and "Inspection Level S-2. AOL 2.5" for Physical and Dimensions Testing. This refers to a statistically defined sampling plan (ANSI/ASQ Z1.4 typically used for AQL), but the absolute number of units sampled is not explicitly stated. The sample size would depend on the batch size being tested.
- Data Provenance: The tests were conducted on the manufacturer's gloves, Tangshan Zhongying Plastic Products Co., Ltd., which is based in Hebei, China. The data is prospective in the sense that these tests were performed on the device manufactured for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes the testing of physical and biological properties of gloves, not evaluation of medical imaging or diagnostic algorithms requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is not relevant to the type of testing performed on examination gloves.
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 is a medical device clearance for examination gloves, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For physical and dimensional testing, the "ground truth" (or reference standard) is established by the definitions and specifications within the ASTM D5250-00 standard.
- For the Water Fill Test (pinholes), the ground truth is defined by the FDA 1000 ml water fill test method and its pass/fail criteria.
- For skin irritation and sensitization, the ground truth is based on standard toxicological testing protocols and evaluation for adverse reactions.
- For powder content, the ground truth is determined by a quantitative gravimetric test method (<= 2mg powder per glove).
8. The sample size for the training set:
- Not Applicable. This document does not pertain to an AI algorithm that requires a training set. The "training" in the context of manufacturing would be the process controls and quality assurance applied during production.
9. How the ground truth for the training set was established:
- Not Applicable. No training set for an AI algorithm is involved.
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510 (K) SUMMARY
FEB 1 7 2009
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
1. Submitter's Identification:
Tangshan Zhongying Plastic Products Co., Ltd. West of Gujiaying Village, Luannan, Tangshan, Hebei, China 063500
Date summary prepared: October 9, 2008
2. Name of the Device:
Tangshan Zhongying Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free
3. Predicate Device Informaton:
Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)
4. Device Description:
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 requirement 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 between healthcare personnel and the patient's body. fluids, waste or environment.
6. Comparison to Predicate Devices:
Tangshan Zhongying Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. and Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Powderfree,
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7. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Tangshan Zhongying Plastic 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. AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 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 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:
Tangshan Zhongying Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tangshan Zhongying Plastic Products Company, Limited C/0 Mr. John Zhao Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
FEB 1 7 2009
Re: K083259
Trade/Device Name: Patient Vinyl Examination Gloves, Powder-free, Non-Sterile Regulation Number: 21 CFR 880.6250 . . . Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 2, 2009 Received: February 3, 2009
Dear Mr. Zhao:
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. Zhao
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
D. 0 Ginette Y. Michaud, M.D. Acting 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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Tangshan Zhongying Plastic Products Co., Ltd.
West of Gujiaying Village, Luannan, Tangshan, Hebei, China 063500
INDICATIONS FOR USE
Tangshan Zhongying Plastic Products Co., Ltd. Applicant:
510(k) Number:
Device Name: Patient Vinyl Examination Gloves, Powderfree, Non-Sterile
Indications of Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Prescription Use
Over the Counter Use X
Factory Initials
Shila K Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.