(362 days)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Powder Free Blue Nitrite Examination Gloves- Tested for Use with Chemotherapy Drugs.
This document describes the FDA's 510(k) clearance for "Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs" (K182089). The primary focus of the performance data in this document relates to the gloves' resistance to permeation by chemotherapy drugs.
Here's an analysis based on your request, using the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for gloves used with chemotherapy drugs are typically defined by regulatory bodies or consensus standards (like ASTM D6978, which is often referenced for chemotherapy glove testing) as a minimum breakthrough time. While explicit "acceptance criteria" values are not stated in this document as a separate column, the reported device performance clearly indicates whether the gloves meet the implied standard of extended protection (often >240 minutes for many drugs).
| Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard practice, e.g., ASTM D6978) | Reported Device Performance (Breakthrough Detection Time) | Meets Implied Criteria? |
|---|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml | Typically >240 min desired | 9.0 min | No (specifically cautioned against) |
| Cisplatin | 1.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Cyclophosphamide (Cytoxan) | 20mg/ml | Typically >240 min desired | >240 min | Yes |
| Dacarbazine (DTIC) | 10.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Doxorubicin Hydrochloride | 2.0mg/ml | Typically >240 min desired | >240 min | Yes |
| Etoposide (Toposar) | 20.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Fluorouracil | 50.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Ifosfamide | 50.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Methotrexate | 25 mg/ml | Typically >240 min desired | >240 min | Yes |
| Mitomycin C | 0.5 mg/ml | Typically >240 min desired | >240 min | Yes |
| Mitoxantrone | 2.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Paclitaxel (Taxol) | 6.0 mg/ml | Typically >240 min desired | >240 min | Yes |
| Thio-Tepa | 10.0 mg/ml | Typically >240 min desired | 16.2 min | No (specifically cautioned against) |
| Vincristine Sulfate | 1.0 mg/ml | Typically >240 min desired | >240 min | Yes |
Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes. Do not use with Carmustine and Thio-Tepa." This indicates that for these two drugs, the gloves did not meet the standard expectation for chemotherapy glove use, and this limitation is clearly communicated.
The subsequent questions (2-9) are primarily relevant to clinical studies involving AI or diagnostics that interpret medical data. This document describes the clearance of a medical device (gloves) based on laboratory testing for chemical permeation, not a clinical study involving human patients, expert readers, or AI algorithms. Therefore, most of these questions are not applicable to the provided information.
However, I will address those that can be inferred or directly commented on:
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in terms of number of gloves tested, but it would involve multiple samples of the glove material subjected to permeation testing according to a standard like ASTM D6978. For each chemotherapy drug listed, a sample of the glove material would be exposed, and the time until breakthrough is detected would be measured.
- Data Provenance: The document implies laboratory testing conducted by the manufacturer or a certified lab. The country of origin of the data is not specified beyond the manufacturer being "Platinum Glove Industries Sdn Bhd" from "Malaysia." This is retrospective testing of the glove material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study involving human interpretation of medical data where "ground truth" is established by experts. The "ground truth" in this context is the physical property of the glove's resistance to chemical permeation, measured by laboratory instrumentation and protocols (e.g., using a permeation cell and analytical detection methods).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 is not a clinical or AI-based diagnostic study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the measured chemical permeation time of specific chemotherapy drugs through the glove material, determined through standardized laboratory testing (e.g., in accordance with ASTM D6978 or an equivalent standard).
8. The sample size for the training set:
- Not Applicable. This is not an AI or machine learning study, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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Image /page/0/Picture/0 description: The image shows 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.
July 30, 2019
Platinum Glove Industries Sdn Bhd % Foo Pu Managing Director Platinum Glove Industries Sdn. Bhd. Lot 6491-A. Batu 5 3/4. Sementa. Jalan Kapar Selangor Darul Ehsan, 42100 My
Re: K182089
Trade/Device Name: Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: June 22, 2018 Received: July 5, 2018
Dear Foo Pu:
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.
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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); 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 mediation-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.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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) K182089
Device Name
Powder Free Blue Nitrite Examination Gloves- Tested for Use with Chemotherapy Drugs.
Indications for Use (Describe)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Chemotherapy Drug permeation (Break through Detection Time) in Minutes. The following chemicals have been tested with these gloves.
| 1. Carmustine (BCNU)3.3 mg/ml(3,300ppm) | 9.0 min |
|---|---|
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml (20,000ppm) | >240 min |
| 4. Dacarbazine (DTIC)1 0.0 mg/ml (10,000ppm) | >240 min |
| 5. Doxorubicin Hydrochloride 2.0mg/ml (2,000ppm) | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | >240 min |
| 10. Mitomycin C 0.5 mg/ml (500ppm) | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | 16.2min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | >240min |
Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes.
Do not use with Carmustine and Thio-Tepa
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.