(90 days)
The Nitrile Glove Powder Free Blue is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is powder free, non-sterile nitrile examination gloves. Following FDA Code LZA, a "nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants."
This document is a 510(k) Premarket Notification for a medical device: Nitrile Glove Powder Free Blue. It seeks to demonstrate substantial equivalence to a predicate device.
The provided text describes the regulatory process, device information, and a comparison of the proposed device with a predicate device, focusing on non-clinical performance testing. It does not contain information about an AI/ML device, nor does it describe a study involving human readers or comparative effectiveness for an AI model.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving an AI/ML device meets those criteria, specifically concerning:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes, data provenance, and ground truth establishment for AI/ML test and training sets.
- Details on expert involvement (number, qualifications, adjudication) for an AI/ML ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies for AI assistance.
- Stand-alone AI algorithm performance.
The document is entirely focused on the physical and chemical properties and safety of a medical glove, not an AI/ML system.
However, I can extract the acceptance criteria and performance data for the Nitrile Glove Powder Free Blue from the provided document, which pertains to its non-clinical testing.
Here's a breakdown of the acceptance criteria and results for the medical glove as presented in the document:
1. A table of acceptance criteria and the reported device performance (for the physical glove)
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-5 Biological evaluation of medical devices Test for in vitro cytotoxicity | To determine the potential cytotoxicity. | Non-cytotoxic | PASS |
| ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for Systemic Toxicity | To determine the potential systemic toxicity. | Does not cause systemic toxicity | PASS |
| ISO 10993-10 Biological evaluation on medical device Part 10: Test for Irritation and Skin Irritation | To determine the potential for irritation and skin irritation. | Non-irritant, and Non skin irritant | PASS |
| ISO 10993-10 Biological evaluation on medical device Part 10: Test Skin Sensitization | To determine the potential skin sensitization. | Does not cause skin sensitization | PASS |
| ASTM D6319, Standard Specification for Nitrile Examination Gloves for Medical Application | To test for: (1) freedom from holes (2) physical dimensions (3) Aging | (1) Shall not leak (2) For size M (mm): Width: 110 +/- 10, Length: ≥ 230, Finger and palm thickness: median value ≥ 0.05 (3) After Aging: Tensile Strength: ≥ 14 MPa, Ultimate elongation: ≥ 400% | PASS |
| EN 455-1, EN 455-2, Medical Gloves For Single Use | To test for: (1) freedom from holes (2) dimensions and strength | (1) Shall not leak (2) For size M (mm): Width: 110, Length: ≥ 240, Strength: Force at Break: ≥ 6N, Force at break after challenge testing ≥ 6N at 7 days | PASS |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes (number of gloves) used for each non-clinical test. It only states the tests were conducted. The data provenance is implied to be from the manufacturer's internal testing or accredited labs in China (Changzhou Universal Medical Equipment Co. Ltd. is located in Changzhou, Jiangsu Province, China). The tests are retrospective in the sense that they were performed on finished products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable to this type of non-clinical testing for a medical glove. The "ground truth" for these tests is established by standardized laboratory methods (e.g., measuring dimensions, performing leak tests, chemical assays for cytotoxicity) according to the specified ISO, ASTM, and EN standards. These are objective measures, not requiring expert consensus or interpretation in the same way an AI model's output would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As noted above, these are objective physical and biological tests, not requiring adjudication of human performance or AI output.
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 document is for a medical glove, not an AI/ML device. No human reader studies were conducted or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. The performance described is the standalone performance of the physical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the glove's performance is based on the results of standardized laboratory engineering and biological tests as defined by ISO, ASTM, and EN standards (e.g., presence/absence of leaks, specific measurements (length, width, thickness), tensile strength, elongation, cytotoxicity, irritation, sensitization).
8. The sample size for the training set:
Not applicable. There is no training set for a physically manufactured medical glove in the context of an AI/ML model.
9. How the ground truth for the training set was established:
Not applicable. There is no training set as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 21, 2021
Changzhou Universal Medical Equipment CO. LTD. % Roxanne Dubois Regulatory Consultant R. Dubois Consulting, LLC 1399 Robnick Ct. Campbell, California 95008
Re: K210145
Trade/Device Name: Nitrile Glove Powder Free Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 31, 2021 Received: April 5, 2021
Dear Roxanne Dubois:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210145
Device Name
Nitrile Glove Powder Free Blue
Indications for Use (Describe)
The Nittile Glove Powder Free Blue is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Changzhou Universal Medical Equipment Co., Ltd. The logo consists of a blue circular emblem with stars around the perimeter and Chinese characters inside. To the right of the emblem is the company name in both Chinese and English. The English translation reads "Changzhou Universal Medical Equipment Co., Ltd."
510(k) Summary - K210145
1.0 Submitter's Information:
| Name: | Changzhou Universal Medical Equipment Co. Ltd |
|---|---|
| Address: | No 6, Xinxi Road, Xinbei District |
| Changzhou, Jiangsu Province, 213000 China | |
| Tel: | +86-519-85483888 |
| Date of Preparation: | January 12, 2021 |
| Contact Person: | Roxanne Dubois |
| Address: | R. Dubois Consulting, LLC |
| 1399 Robnick Ct., Campbell, CA 95008 | |
| Tel: | 408-828-5019 |
| Email: | rduboisconsulting@gmail.com |
2.0 Device Information
| Trade name: | Nitrile Glove Powder Free Blue |
|---|---|
| Common name: | Patient Examination Gloves |
| Regulation name: | Non-powdered patient examination glove |
3.0 Classification
| Production code: | LZA |
|---|---|
| Regulation number: | 21 CFR 880.6250 |
| Classification: | Class I |
| Panel: | General Hospital |
4.0 Predicate Device Information
| Manufacturer: | Haining Medical Products Co. Ltd |
|---|---|
| Device: | Nitrile Glove Powder Free White |
| 510(k) number: | K183068 |
5.0 Indications for Use
The Nitrile Glove Powder Free Blue is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device Description
The proposed device is powder free, non-sterile nitrile examination gloves.
Following FDA Code LZA, a "nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants."
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7.0 Technological Characteristic Comparison Table
| Table 1 General Comparison |
|---|
| ---------------------------- |
| Topic | Proposed Device | Predicate Device(K183068) | Comparison |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No | 21 CFR 880.6250Non-powdered patientexamination glove | 21 CFR 880.6250Non-powdered patientexamination glove | Same |
| Identification | A non-powdered patientexamination glove is adisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination between patientand examiner. | A non-powdered patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand or fingerto preventcontamination betweenpatient and examiner. | Same |
| Class | Class I reserved medicaldevices that require a 510(k)premarket notification | Class I reserved medical devicesthat require a 510(k) premarketnotification. | Same |
| Indications For Use | The Nitrile Glove PowderFree Blue is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hands to preventcontaminationbetween patient and examiner. | The Nitrile Glove Powder FreeBlue is a disposable deviceintended for medical purposesthat is worn on the examiner'shands to prevent contaminationbetween patient and examiner. | Same |
| Powdered or PowderFree | Non-powdered | Non-powdered | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication,powder free, device color,device name, glove sizeand quantity, Nitrile GlovePowder-Free, Non Sterile | Single-use indication, powderfree, device color, devicename, glove size and quantity,Nitrile Glove Powder-Free,Non Sterile | Same |
| Dimensions | Length:230 mmWidth:85-115 mmThickness:0.05 mm | Length:230 mmWidth:85-115 mmThickness: 0.05 mm | Same |
| Colorant | Blue | White | Different |
8.0 Discussion of Non-clinical and Performance Testing
Non-clinical tests were conducted to verify that the proposed device meets all design specifications, the FDA-recognized consensus standard, proposed labeling claims and pinhole acceptable quality level (AQL). The relevant standards and test results are provided below.
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Table 2 Relevant Standards and Test Results
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5 Biologicalevaluation of medicaldevices Test for in vitrocytotoxicity | To determine thepotentialcytotoxicity. | Non-cytotoxic | PASS |
| ISO 10993-11 Biologicalevaluation of medicaldevices Part 11: Tests forSystemic Toxicity | To determine thepotential systemictoxicity. | Does not cause systemic toxicity | PASS |
| ISO 10993-10 Biologicalevaluation on medicaldevice Part 10: Test forIrritation and SkinIrritation | To determine thepotential forirritation and skinirritation. | Non-irritant, andNon skin irritant | PASS |
| ISO 10993-10 Biologicalevaluation on medicaldevice Part 10: Test SkinSensitization | To determine thepotential skinsensitization. | Does not cause skin sensitization | PASS |
| ASTM D6319, StandardSpecification for NitrileExamination Gloves forMedical Application | To test for:(1) freedom fromholes(2) physicaldimensions(3) Aging | (1) Shall not leak(2) For size M (mm):Width: 110 +/- 10Length: $≥$ 230Finger and palm thickness:median value $≥$ 0.05(3) After Aging:Tensile Strength: $≥$ 14 MPaUltimate elongation: $≥$ 400% | PASS |
| EN 455-1, EN 455-2,Medical Gloves ForSingle Use | To test for:(1) freedom fromholes(2) dimensions andstrength | (1) Shall not leak(2) For size M (mm):Width: 110Length: $≥$ 240Strength:Force at Break: $≥$ 6NForce at break after challengetesting $≥$ 6N at 7 days | PASS |
9.0 Discussion of Clinical Testing
Clinical testing was not required to support this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the predicate device.
§ 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.