(67 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
| Blue | |
|---|---|
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 11.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | 7.4 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate:
| Blue | |
|---|---|
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 30.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | 91.0 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
| Busulfan, 6 mg/ml | > 240 minutes |
| Cytarabine, 100 mg/ml | > 240 minutes |
| Daunorubicin, 5 mg/ml | > 240 minutes |
| Docetaxel, 10 mg/ml | > 240 minutes |
| Epirubicin, 2 mg/ml | > 240 minutes |
| Gemcitabine, 38 mg/ml | > 240 minutes |
| Irinotecan Hydrochloride, 20 mg/ml | > 240 minutes |
| Mechlorethamine HCL, 1.0 mg/ml | > 240 minutes |
| Melphalan, 5 mg/ml | > 240 minutes |
| Trisenox, 0.1 mg/ml | > 240 minutes |
| Fentanyl Citrate, 100mcg/2ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 30.3 minutes ThioTEPA (10.0 mg/ml): 91.0 minutes
CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS
Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue; Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue
This document describes two types of non-sterile, powder-free nitrile examination gloves:
- Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue
- Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue
The acceptance criteria for both devices are primarily based on their resistance to permeation by chemotherapy drugs, as tested according to ASTM D6978 Standard Practice. For the second device, resistance to Fentanyl Citrate is also included.
The study proving the device meets the acceptance criteria is detailed in the "Indications for Use" sections for each glove type.
1. Table of Acceptance Criteria and Reported Device Performance
Device 1: Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue
| Tested Chemotherapy Drug And Concentration | Acceptance Criterion (Minimum Breakthrough Detection Time) | Reported Device Performance (Average Breakthrough Detection Time) |
|---|---|---|
| Carboplatin, 10 mg/ml | Not explicitly stated (implied for medical use performance) | > 240 minutes |
| Carmustine, 3.3 mg/ml | Not explicitly stated | 11.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | Not explicitly stated | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | Not explicitly stated | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | Not explicitly stated | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | Not explicitly stated | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | Not explicitly stated | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | Not explicitly stated | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | Not explicitly stated | > 240 minutes |
| Methotrexate, 25 mg/ml | Not explicitly stated | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | Not explicitly stated | > 240 minutes |
| Mitoxantrone, 2 mg/ml | Not explicitly stated | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | Not explicitly stated | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | Not explicitly stated | 7.4 minutes |
| Vincristine Sulfate, 1.0 mg/ml | Not explicitly stated | > 240 minutes |
Note: The document explicitly warns: "WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA" due to their extremely low permeation times (11.3 minutes and 7.4 minutes, respectively). This implicitly sets an acceptance criterion that usage with these drugs is not recommended, rather than a performance threshold for them. For other drugs, a permeation time of "> 240 minutes" appears to be the target performance for safe use.
Device 2: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue
| Tested Chemotherapy Drug And Concentration | Acceptance Criterion (Minimum Breakthrough Detection Time) | Reported Device Performance (Average Breakthrough Detection Time) |
|---|---|---|
| Carboplatin, 10 mg/ml | Not explicitly stated (implied for medical use performance) | > 240 minutes |
| Carmustine, 3.3 mg/ml | Not explicitly stated | 30.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | Not explicitly stated | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | Not explicitly stated | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | Not explicitly stated | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | Not explicitly stated | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | Not explicitly stated | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | Not explicitly stated | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | Not explicitly stated | > 240 minutes |
| Methotrexate, 25 mg/ml | Not explicitly stated | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | Not explicitly stated | > 240 minutes |
| Mitoxantrone, 2 mg/ml | Not explicitly stated | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | Not explicitly stated | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | Not explicitly stated | 91.0 minutes |
| Vincristine Sulfate, 1.0 mg/ml | Not explicitly stated | > 240 minutes |
| Busulfan, 6 mg/ml | Not explicitly stated | > 240 minutes |
| Cytarabine, 100 mg/ml | Not explicitly stated | > 240 minutes |
| Daunorubicin, 5 mg/ml | Not explicitly stated | > 240 minutes |
| Docetaxel, 10 mg/ml | Not explicitly stated | > 240 minutes |
| Epirubicin, 2 mg/ml | Not explicitly stated | > 240 minutes |
| Gemcitabine, 38 mg/ml | Not explicitly stated | > 240 minutes |
| Irinotecan Hydrochloride, 20 mg/ml | Not explicitly stated | > 240 minutes |
| Mechlorethamine HCL, 1.0 mg/ml | Not explicitly stated | > 240 minutes |
| Melphalan, 5 mg/ml | Not explicitly stated | > 240 minutes |
| Trisenox, 0.1 mg/ml | Not explicitly stated | > 240 minutes |
| Fentanyl Citrate, 100mcg/2ml | Not explicitly stated | > 240 minutes |
Note: The document states: "CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS". Similar to Device 1, this indicates that while tested, their permeation times (30.3 minutes and 91.0 minutes, respectively) are lower than the target for other drugs, suggesting a cautionary use or implicit lower acceptance for these specific substances.
2. Sample size used for the test set and the data provenance
The document specifies that the gloves were "tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
- Sample Size for the Test Set: The document does not explicitly state the sample size (e.g., number of gloves or tests performed per drug) used for these tests. The ASTM D6978 standard would likely specify the required number of replicates.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. The testing was conducted by YTY Industry (Manjung) Sdn Bhd, located in Malaysia, suggesting the tests were performed in Malaysia. The nature of laboratory testing like this is inherently prospective for the specific batch or design of gloves being evaluated.
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 in the context of this document. The "ground truth" here is the physical measurement of chemical permeation, determined by laboratory testing methods described in ASTM D6978, rather than expert interpretation of medical images or diagnostic data. There is no indication of experts being used to establish a ground truth for the test results.
4. Adjudication method for the test set
This question is not applicable. The test results are objective chemical permeation measurements (breakthrough detection time), not subjective interpretations that require adjudication by experts.
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. The device is a medical glove, not an AI-powered diagnostic tool requiring human interpretation or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a medical glove, not an algorithm. The performance described is that of the physical product itself.
7. The type of ground truth used
The ground truth used is laboratory measurement of chemical permeation according to the ASTM D6978 standard. This standard describes methods to evaluate the resistance of medical gloves to permeation by chemotherapy drugs, typically by detecting the breakthrough of a specific chemical through the glove material over time.
8. The sample size for the training set
This question is not applicable. The device consists of physical gloves, not a machine learning model, and therefore does not have a "training set" in the computational sense. The manufacturing process of gloves might involve quality control and material testing, but this is distinct from training a dataset for an algorithm.
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this physical 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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font.
May 1, 2020
YTY Industry (Manjung) Sdn Bhd Punitha Samy Senior Manager (YTY Group DCRA & YTY Industry QA) Lot 1422-1424, Batu 10 Lekir Sitiawan, Perak 32020 Malaysia
Re: K200453
Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue; Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved
Dated: February 17, 2020
Product Code: LZA, LZC, QDO
Received: February 24, 2020
Dear Punitha Samy:
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.
{1}------------------------------------------------
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 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,
CAPT Elizabeth Claverie, M.S. 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) K200453
Device Name
Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
| Blue | |
|---|---|
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 11.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | 7.4 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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{4}------------------------------------------------
Indications for Use
510(k) Number (if known) K200453
Device Name
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Cirate - Blue
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate:
| Blue | |
|---|---|
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 30.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | 91.0 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
| Busulfan, 6 mg/ml | > 240 minutes |
| Cytarabine, 100 mg/ml | > 240 minutes |
| Daunorubicin, 5 mg/ml | > 240 minutes |
| Docetaxel, 10 mg/ml | > 240 minutes |
| Epirubicin, 2 mg/ml | > 240 minutes |
| Gemcitabine, 38 mg/ml | > 240 minutes |
| Irinotecan Hydrochloride, 20 mg/ml | > 240 minutes |
| Mechlorethamine HCL, 1.0 mg/ml | > 240 minutes |
| Melphalan, 5 mg/ml | > 240 minutes |
| Trisenox, 0.1 mg/ml | > 240 minutes |
| Fentanyl Citrate, 100mcg/2ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 30.3 minutes ThioTEPA (10.0 mg/ml): 91.0 minutes
CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS
{5}------------------------------------------------
Prescription Use (Part 21 CFR 801 Subpart D)
- X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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.