(233 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim
This document is an FDA 510(k) clearance letter for "Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim." It primarily focuses on the substantial equivalence determination for this medical device and its performance against specific chemical permeation tests.
Given the nature of the document, which pertains to a physical medical device (gloves) and not an AI/ML-driven device or diagnostic tool, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic performance (e.g., sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable.
The "acceptance criteria" and "study" described in the document relate to the gloves' physical and chemical barrier properties, specifically:
- Low Dermatitis Potential: Demonstrated reduced potential for sensitizing users to chemical additives. (The document doesn't detail the specific study methodology for this, but it implies a test was conducted.)
- Chemotherapy Drug Permeation Resistance: Tested for permeation using ASTM D6978-05.
- Fentanyl Permeation Resistance: Tested for permeation using ASTM D6978-05.
Here's how the provided information fits the closest possible interpretation of your request for this type of device:
Acceptance Criteria and Device Performance (for physical/chemical properties):
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Barrier to Chemotherapy Drugs (Demonstrate sufficient permeation resistance for a range of commonly used chemotherapy drugs when tested according to ASTM D6978-05) | Minimum Breakthrough Detection Time (minutes):- Bleomycin Sulfate: >240- Busulfan: >240- Carboplatin: >240- Carmustine: 12.4- Cisplatin: >240- Chloroquine: >240- Cyclophosphamide: >240- Cyclosporin: >240- Cytarabine HCl: >240- Dacarbazine: >240- Daunorubicin HCl: >240- Docetaxel: >240- Doxorubicin Hydrochloride: >240- Epirubicin (Ellence): >240- Etoposide: >240- Fludarabine: >240- Fluorouracil: >240- Gemcitabine: >240- Idarubicin: >240- Ifosfamide: >240- Irinotecan: >240- Mechlorethamine HCl: >240- Melphalan: >240- Methotrexate: >240- Mitomycin: >240- Mitoxantrone: >240- Oxaliplatin: >240- Paclitaxel: >240- Paraplatin: >240- Retrovir: >240- Rituximab: >240- Thiotepa: 24.4- Topotecane: >240- Trisonex: >240- Velcade: >240- Vincristine Sulfate: >240Note: Carmustine and Thiotepa showed significantly lower permeation times, which the labeling explicitly highlights. |
| Barrier to Fentanyl Citrate Injection (Demonstrate resistance to fentanyl permeation when tested according to ASTM D6978-05) | Fentanyl Citrate Injection (100mcg/2mL): No breakthrough detected up to 240 minutes. |
| Low Dermatitis Potential (Demonstrate reduced potential for sensitizing users to chemical additives) | Demonstrated reduced potential for sensitizing users to chemical additives. |
Regarding the specific questions tailored for AI/ML or diagnostic performance studies:
- Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to chemical permeation tests on glove samples, not patient data for an AI algorithm. The provenance would be the gloves themselves and the chemicals used in the ASTM D6978-05 standard.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. "Ground truth" for this device is established by chemical analysis according to a standardized protocol (ASTM D6978-05), not by human expert opinion on images or clinical cases.
- Adjudication method: Not applicable. Chemical tests follow a protocol, not an adjudication process.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in diagnostic tasks.
- If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used: For chemical resistance, the ground truth is the quantitative measurement of breakthrough time according to a standardized chemical test (ASTM D6978-05). For low dermatitis, it would be results from a dermatological irritation/sensitization test.
- The sample size for the training set: Not applicable. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, this FDA document is for a conventional Class I medical device (nitrile examination gloves) and its clearance is based on laboratory testing of its physical and chemical properties, not on AI/ML performance or diagnostic accuracy studies.
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July 4, 2019
Central Medicare Sdn. Bhd. Muhammad Rahman Product Assistant Manager PT 2609-2620, BT 8, Jalan Changkat Jong Teluk Intan, 36000 My
Re: K183149
Trade/Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA, ODO Dated: May 30, 2019 Received: June 3, 2019
Dear Muhammad Rahman:
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K183149
Device Name
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatits and Fentanyl Permeation Resistance Claim
Indications for Use (Describe)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
| Tested Chemotherapy Drug | Concentrate(mg/ml) | Minimum Breakthrough Detection Time (minutes) |
|---|---|---|
| Bleomycin Sulfate | 15 | >240 |
| Busulfan | 6 | >240 |
| Carboplatin | 10 | >240 |
| *Carmustine | 3.3 | 12.4 |
| Cisplatin | 1 | >240 |
| Chloroquine | 50 | >240 |
| Cyclophosphamide | 20 | >240 |
| Cyclosporin | 100 | >240 |
| Cytarabine HCI | 100 | >240 |
| Dacarbazine | 10 | >240 |
| Daunorubicin HCI | 5 | >240 |
| Docetaxel | 10 | >240 |
| Doxorubicin Hydrochloride | 2 | >240 |
| Epirubicin (Ellence) | 2 | >240 |
| Etoposide | 20 | >240 |
| Fludarabine | 25 | >240 |
| Fluorouracil | 50 | >240 |
| Gemcitabine | 38 | >240 |
| Idarubicin | 1 | >240 |
| Ifosfamide | 50 | >240 |
| Irinotecan | 20 | >240 |
| Mechlorethamine HCI | 1 | >240 |
| Melphalan | 5 | >240 |
| Methotrexate | 25 | >240 |
| Mitomycin | 0.5 | >240 |
| Mitoxantrone | 2 | >240 |
| Oxaliplatin | 5 | >240 |
| Paclitaxel | 6 | >240 |
| Paraplatin | 10 | >240 |
| Retrovir | 10 | >240 |
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| Rituximab | 10 | >240 |
|---|---|---|
| *Thiotepa | 10 | 24.4 |
| Topotecane | 1 | >240 |
| Trisonex | 1 | >240 |
| Velcade | 1 | >240 |
| Vincristine Sulfate | 1 | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 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.