(123 days)
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
This document is a 510(k) clearance letter from the FDA for a new medical device, specifically examination gloves. It does not describe an AI/ML powered device, and therefore the majority of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable.
However, I can extract the relevant "acceptance criteria" for the gloves in terms of their resistance to chemotherapy drugs and other solutions, as presented in the document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for these gloves are implicitly defined by their performance against the listed chemicals, demonstrating their barrier effectiveness by reporting breakthrough times according to ASTM D6978-05 (2019). The goal is to show a reasonably long breakthrough time for protection. While specific pass/fail thresholds are not explicitly stated as "acceptance criteria" in a quantitative sense here, the reported times indicate the device's protective capabilities.
| Chemotherapy Drug and Concentration | Black Color (Reported Performance - Breakthrough Time) | Gray Color (Reported Performance - Breakthrough Time) |
|---|---|---|
| Carmustine (BCNU), 3.3mg/ml | 84.3 mins | 54 mins |
| Cisplatin, 1.0mg/ml | >240 mins | >240 mins |
| Cyclophosphamide (Cytoxan), 20mg/ml | >240 mins | >240 mins |
| Dacarbazine (DTIC), 10mg/ml | >240 mins | >240 mins |
| Doxorubicin Hydrochloride, 2.0mg/ml | >240 mins | >240 mins |
| Etoposide (Toposar), 20mg/ml | >240 mins | >240 mins |
| Fluorouracil, 50mg/ml | >240 mins | >240 mins |
| Paclitaxel (Taxol), 6.0mg/ml | >240 mins | >240 mins |
| Thiotepa, 10mg/ml | 116.2 mins | 109.4 mins |
| Fentanyl Citrate, 100mcg/2ml | >240 mins | >240 mins |
| Simulated Gastric Acid | >240 mins | >240 mins |
| Fentanyl-Simulated Gastric Acid Solution 50/50 | >240 mins | >240 mins |
Note: The document explicitly highlights lower breakthrough times for Carmustine and Thiotepa as a "CAUTION," indicating these values are notable and potentially below a desired threshold, though a hard "failure" isn't stated for regulatory clearance.
The rest of the requested information (points 2-9) is not applicable to this document because it describes a physical medical device (examination gloves), not an AI/ML-powered software. Therefore, there is no mention of:
- Sample size used for an AI test set or data provenance.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI model.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth (beyond chemical testing results).
- Training set size or how its ground truth was established.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 28, 2022
Shen Wei USA Inc. Cheryl Reep Compliance Director 33278 Central Ave Ste 102 Union City, California 94587
Re: K213142
Trade/Device Name: Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: December 20, 2021 Received: January 5, 2022
Dear Cheryl Reep:
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, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213142
Device Name
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotheray drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
Indications for Use (Describe)
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Breakthrough times per ASTM D6978-05 (2019)
| Chemotherapy Drug and Concentration | Black Color | Gray Color |
|---|---|---|
| Carmustine (BCNU)), 3.3mg/ml | 84.3mins | 54mins |
| Cisplatin, 1.0mg/ml | >240mins | >240mins |
| Cyclophosphamide (Cytoxan), 20mg/ml | >240mins | >240mins |
| Dacarbazine (DTIC), 10mg/ml | >240mins | >240mins |
| Doxorubicin Hydrochloride, 2.0mg/ml | >240mins | >240mins |
| Etoposide (Toposar), 20mg/ml | >240mins | >240mins |
| Fluorouracil, 50mg/ml | >240mins | >240mins |
| Paclitaxel (Taxol), 6.0mg/ml | >240mins | >240mins |
| Thiotepa, 10mg/ml | 116.2mins | 109.4mins |
| Fentanyl Citrate, 100mcg/2ml | >240mins | >240mins |
| Simulated Gastric Acid | >240mins | >240mins |
| Fentanyl-Simulated Gastric Acid Solution 50/50 | >240mins | >240mins |
CAUTION: Testing showed an average breakthrough time for Carmustine at 84.3minutes and 54minutes. Thiotepa at 116.2 minutes and 109.4 minutes.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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.