(103 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 D5250-06.
The provided text describes a 510(k) premarket notification for "Zibo Litong Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free." This is a Class I medical device (patient examination glove), which, by its nature, does not typically involve AI components or complex diagnostic algorithms. Therefore, the specific questions regarding AI performance metrics, expert adjudication, MRMC studies, and ground truth establishment for AI models are not applicable to this type of medical device submission.
The acceptance criteria and studies focus on the physical properties and biocompatibility of the gloves, ensuring they meet established ASTM standards and FDA requirements for patient examination gloves.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ASTM D5250-06 (Physical and Dimensions Testing) | Meets all requirements (Inspection Level S-2, AQL 2.5) |
| FDA 1000 ml Water Fill Test (Pinhole integrity) | Meets requirements (AQL 2.5, Inspection Level I) |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions |
| Powder-Free Claim (≤ 2 mg powder per glove) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
| Overall Conformity | Conforms fully to ASTM-D-5250-06 standard and applicable 21 CFR references (e.g., 21 CFR 880.6250) |
| Biocompatibility | Meets biocompatibility requirements |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection Level S-2, AQL 2.5. (Specific sample size not explicitly stated, but determined by ASTM D5250-06 and the AQL).
- Water Fill Test: AQL 2.5, Inspection Level I. (Specific sample size not explicitly stated, but determined by FDA requirements and the AQL).
- Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but implied to be conducted on relevant biological samples.
- Data Provenance: The device is manufactured by Zibo Litong Plastic Products Co., Ltd. in Zibo, China. The testing was conducted to meet US FDA and ASTM standards. The text does not specify the country of origin for the "data" from skin irritation/sensitization tests, but typically, these tests are performed in accredited labs. The studies are essentially "retrospective" in the sense that the testing was performed on manufactured gloves to demonstrate compliance for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. The "ground truth" for glove performance is established by objective physical and chemical testing against defined standards (ASTM and FDA). It does not involve expert readers or diagnostic interpretations.
4. Adjudication method for the test set
- This question is not applicable. Adjudication is relevant for subjective assessments, primarily in clinical trials or image interpretation. Glove testing involves objective measurements.
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
- This question is not applicable. This device is a medical glove, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. There is no AI algorithm in this device.
7. The type of ground truth used
- For physical and performance characteristics: Objective measurements against defined industry standards (ASTM D5250-06) and regulatory requirements (FDA 1000 ml Water Fill Test, chemical analysis for powder content).
- For biocompatibility: Results from primary skin irritation and skin sensitization tests.
8. The sample size for the training set
- This question is not applicable. There is no "training set" in the context of an AI model for this device. The manufacturing process is controlled to consistently produce gloves that meet the specifications, but there isn't a machine learning training phase.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as point 8.
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JAN 1 2 2009
510 (K) SUMMARY
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:
Zibo Litong Plastic Products Co., Ltd Long Chang Road, Zhoujia District, Zibo, China Tel: 011-86-533-3819098
Date summary prepared: October 9, 2008
2. Name of the Device:
Zibo Litong 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 D5250-06.
ડ. 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:
Zibo Litong 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 Zibo Litong Plastic Products Co., Ltd. glove production are based on ASTM-D-5250-06. 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.
ರು. Conclusions:
Zibo Litong Plastic Products Co., Ltd.. Synthetic Vinyl Patient Examination Gloves, Powder-Free conform fully to ASTM-D-5250-06 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
JAN 1 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zibo Litong Plastic Products Company, Limited C/O Mr. John Zhao Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
Re: K082936
Trade/Device Name: Patient Vinyl Examination Gloves, Powderfree, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 18, 2008 Received: December 22, 2008
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 (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 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 yours,
Suite H. Michael Dus.
Ginette Y. Michaud. M. D. Acting Division Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Zibo Litony Plastic Products Co., Ltd. Longchang Road, Zhoujia District Zibo, Shandong, China
INDICATIONS FOR USE
Zibo Litong Plastic Products Co., Ltd. Applicant:
K082936 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
Shela M. Murphy
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082936
§ 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.