(167 days)
The glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
The provided document is a 510(k) premarket notification approval letter for Nitrile Powder-Free Exam Gloves. It details the device's substantial equivalence to existing predicate devices and lists the results of permeation tests for various chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid.
However, the document does not describe a study involving an AI/software medical device requiring ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies. The "acceptance criteria" discussed in this document relate to the gloves' resistance to permeation by specific chemicals, measured in "Minimum Breakthrough Detection Time."
Therefore, based solely on the provided text, it is not possible to answer the questions related to AI/software device performance, expert ground truth, adjudication methods, or MRMC studies.
Here's an attempt to answer the questions based on the information available in the document, acknowledging that most questions are not applicable to this type of device:
Acceptance Criteria and Device Performance for Nitrile Powder-Free Exam Gloves
The study presented here is a series of permeation tests conducted to determine the resistance of Nitrile Powder-Free Exam Gloves to various hazardous substances, specifically chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid. The acceptance criteria are implicit in the detailed breakthrough detection times, aiming to demonstrate the gloves' barrier properties against these substances. The tests were performed in accordance with ASTM D6978-05 standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document directly states the "Minimum Breakthrough Detection Time" for each substance for both the Light Blue and Dark Blue gloves. The implicit acceptance criterion would be that the gloves demonstrate a sufficiently long breakthrough time (ideally >240 minutes) for safe handling, or to clearly identify substances for which the gloves are not suitable. The reported performance is the actual measured breakthrough time.
Light Blue Glove Performance:
| Chemotherapy Drug / Substance | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| Bendamustine HCl, 5 mg/ml | >240 min |
| Bortezomib (Velcade), 1 mg/ml | >240 min |
| Busulfan, 6 mg/ml | >240 min |
| Carboplatin, 10 mg/ml | >240 min |
| Carmustine, 3.3 mg/ml | 12.6 min. |
| Carfilzomib, 2 mg/ml | >240 min |
| Cetuximab (Erbitux), 2 mg/ml | >240 min |
| Chloroquine, 50mg/ml | >240 min |
| Cisplatin, 1 mg/ml | >240 min |
| Cladribine, 1.0 mg/ml | >240 min |
| Cyclophosphamide, 20 mg/ml | >240 min |
| Cyclosporin A,100mg/ml | >240 min |
| Cytarabine HCl, 100 mg/ml | >240 min |
| Cytovene, 10 mg/ml | >240 min |
| Dacarbazine, 10 mg/ml | >240 min |
| Daunorubicin HCl, 5 mg/ml | >240 min |
| Decitabine, 5 mg/ml | >240 min |
| Docetaxel, 10 mg/ml | >240 min |
| Doxorubicin HCl, 2 mg/ml | >240 min |
| Epirubicin HCl, 2 mg/ml | >240 min |
| Etoposide, 20 mg/ml | >240 min |
| Fludarabine Phosphate, 25 mg/ml | >240 min |
| 5-Fluorouracil, 50 mg/ml | >240 min |
| Gemcitabine HCl, 38 mg/ml | >240 min |
| Idarubicin HCl, 1 mg/ml | >240 min |
| Ifosfamide, 50 mg/ml | >240 min |
| Irinotecan HCl, 20 mg/ml | >240 min |
| Mechlorethamine HCl, 1 mg/ml | >240 min |
| Melphalan HCl, 5 mg/ml | >240 min |
| Methotrexate, 25 mg/ml | >240 min |
| Mitomycin-C, 0.5 mg/ml | >240 min |
| Mitoxantrone HCl, 2 mg/ml | >240 min |
| Oxaliplatin, 2 mg/ml | >240 min |
| Paclitaxel, 6 mg/ml | >240 min |
| Retrovir, 10 mg/ml | >240 min |
| ThioTEPA, 10 mg/ml | 27.1 min. |
| Trisonex, 1 mg/ml | >240 min |
| Vidaza (Azacitidine), 25 mg/ml | >240 min |
| Vincristine Sulfate, 1 mg/ml | >240 min |
| Fentanyl Citrate Injection, 50mcg/ml | >240 min |
| Gastric Acid | >240 min |
| Fentanyl Citrate:Xylazine HCl, 50:50 | >240 min |
Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.
Dark Blue Glove Performance:
| Chemotherapy Drug / Substance | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| Bendamustine HCl, 5 mg/ml | >240 min |
| Bortezomib (Velcade), 1 mg/ml | >240 min |
| Busulfan, 6 mg/ml | >240 min |
| Carboplatin, 10 mg/ml | >240 min |
| Carmustine, 3.3 mg/ml | 11.0 min. |
| Carfilzomib, 2 mg/ml | >240 min |
| Cetuximab (Erbitux), 2 mg/ml | >240 min |
| Chloroquine, 50mg/ml | >240 min |
| Cisplatin, 1 mg/ml | >240 min |
| Cladribine, 1.0 mg/ml | >240 min |
| Cyclophosphamide, 20 mg/ml | >240 min |
| Cyclosporin A,100mg/ml | >240 min |
| Cytarabine HCl, 100 mg/ml | >240 min |
| Cytovene, 10 mg/ml | >240 min |
| Dacarbazine, 10 mg/ml | >240 min |
| Daunorubicin HCl, 5 mg/ml | >240 min |
| Decitabine, 5 mg/ml | >240 min |
| Docetaxel, 10 mg/ml | >240 min |
| Doxorubicin HCl, 2 mg/ml | >240 min |
| Epirubicin HCl, 2 mg/ml | >240 min |
| Etoposide, 20 mg/ml | >240 min |
| Fludarabine Phosphate, 25 mg/ml | >240 min |
| 5-Fluorouracil, 50 mg/ml | >240 min |
| Gemcitabine HCl, 38 mg/ml | >240 min |
| Idarubicin HCl, 1 mg/ml | >240 min |
| Ifosfamide, 50 mg/ml | >240 min |
| Irinotecan HCl, 20 mg/ml | >240 min |
| Mechlorethamine HCl, 1 mg/ml | >240 min |
| Melphalan HCl, 5 mg/ml | >240 min |
| Methotrexate, 25 mg/ml | >240 min |
| Mitomycin-C, 0.5 mg/ml | >240 min |
| Mitoxantrone HCl, 2 mg/ml | >240 min |
| Oxaliplatin, 2 mg/ml | >240 min |
| Paclitaxel, 6 mg/ml | >240 min |
| Retrovir, 10 mg/ml | >240 min |
| ThioTEPA, 10 mg/ml | 26.0 min. |
| Trisonex, 1 mg/ml | >240 min |
| Vidaza (Azacitidine), 25 mg/ml | >240 min |
| Vincristine Sulfate, 1 mg/ml | >240 min |
| Fentanyl Citrate Injection, 50mcg/ml | >240 min |
| Gastric Acid | >240 min |
| Fentanyl Citrate:Xylazine HCl, 50:50 | >240 min |
Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.
2. Sample Size and Data Provenance for the Test Set:
The document does not explicitly state the sample size (number of gloves tested for each substance) used for these permeation tests. It only lists the test results. The data provenance is stated as being tested "in accordance with ASTM D6978-05 standards," which implies a standardized laboratory testing setting. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable to this type of device and study. The "ground truth" here is the physical measurement of chemical permeation, which is determined by laboratory instrumentation and protocols defined by the ASTM standard, not by human expert interpretation or consensus.
4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human readers/experts evaluating data (e.g., medical images) to establish a consensus ground truth. In this study, the "ground truth" is a direct physical measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. MRMC studies are performed for AI/software devices where human readers interpret medical data, often comparing human performance with and without AI assistance. This document describes chemical permeation tests of gloves, not a diagnostic or prognostic medical device involving human interpretation.
6. Standalone (Algorithm Only) Performance:
This section is not applicable. This refers to the performance of an AI algorithm without human intervention. The device in question is a physical glove, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this study is a physical measurement of chemical permeation through the glove material, determined by laboratory testing protocols as defined by the ASTM D6978-05 standards. It is not derived from expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
This section is not applicable. This study does not involve a training set as it's not an AI/machine learning model development context.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable for the reasons stated above.
U.S. Food & Drug Administration
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
July 9, 2025
Basic Medical Technology Inc.
John Zhao
General manager
5300 Concours Street
Ontario, California 91764
Re: K250193
Trade/Device Name: Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-powdered patient examination glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, OPJ, QDO
Dated: June 20, 2025
Received: June 20, 2025
Dear John Zhao:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. FOOD & DRUG ADMINISTRATION
July 9, 2025
Basic Medical Technology Inc.
John Zhao
General manager
5300 Concours Street
Ontario, California 91764
Re: K250193
Trade/Device Name: Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-powdered patient examination glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, OPJ, QDO
Dated: June 20, 2025
Received: June 20, 2025
Dear John Zhao:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 2
K250193 - John Zhao Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K250193 - John Zhao Page 3
Sincerely,
ALLAN GUAN -S
For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection
Control Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 07/31/2026 |
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K250193
Device Name
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
Indications for Use (Describe)
The glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Light Blue glove:
Chemotherapy Drugs Minimum Breakthrough Detection Time, minutes
- Bendamustine HCl, 5 mg/ml - >240 min
- Bortezomib (Velcade), 1 mg/ml - >240 min
- Busulfan, 6 mg/ml - >240 min
- Carboplatin, 10 mg/ml - >240 min
- Carmustine, 3.3 mg/ml - 12.6 min.
- Carfilzomib, 2 mg/ml - >240 min.
- Cetuximab (Erbitux), 2 mg/ml - >240 min.
- Chloroquine, 50mg/ml - >240 min.
- Cisplatin, 1 mg/ml - >240 min.
- Cladribine, 1.0 mg/ml - >240 min.
- Cyclophosphamide, 20 mg/ml - >240 min.
- Cyclosporin A,100mg/ml - >240 min.
- Cytarabine HCl, 100 mg/ml - >240 min.
- Cytovene, 10 mg/ml - >240 min.
- Dacarbazine, 10 mg/ml - >240 min.
- Daunorubicin HCl, 5 mg/ml - >240 min.
- Decitabine, 5 mg/ml - >240 min.
- Docetaxel, 10 mg/ml - >240 min.
- Doxorubicin HCl, 2 mg/ml - >240 min.
- Epirubicin HCl, 2 mg/ml - >240 min.
- Etoposide, 20 mg/ml - >240 min.
- Fludarabine Phosphate, 25 mg/ml - >240 min.
- 5-Fluorouracil, 50 mg/ml - >240 min.
- Gemcitabine HCl, 38 mg/ml - >240 min.
- Idarubicin HCl, 1 mg/ml - >240 min.
- Ifosfamide, 50 mg/ml - >240 min.
- Irinotecan HCl, 20 mg/ml - >240 min.
- Mechlorethamine HCl, 1 mg/ml - >240 min.
- Melphalan HCl, 5 mg/ml - >240 min.
- Methotrexate, 25 mg/ml - >240 min.
- Mitomycin-C, 0.5 mg/ml - >240 min.
- Mitoxantrone HCl, 2 mg/ml - >240 min.
- Oxaliplatin, 2 mg/ml - >240 min.
- Paclitaxel, 6 mg/ml - >240 min.
- Retrovir, 10 mg/ml - >240 min.
FORM FDA 3881 (8/23) Page 1 of 3 PSC Publishing Services (301) 443-6740 EF
Page 5
- ThioTEPA, 10 mg/ml - 27.1 min.
- Trisonex, 1 mg/ml - >240 min.
- Vidaza(Azacitidine),25 mg/ml - >240 min.
- Vincristine Sulfate,1 mg/ml - >240 min.
Fentanyl, Gastric Acid and Xylazine Minimum Breakthrough Detection Time
- Fentanyl Citrate Injection,50mcg/ml - >240 min.
- Gastric Acid - >240 min.
- Fentanyl Citrate: Xylazine HCl, 50:50 - >240 min.
*Please note that the following drugs have extremely low permeation times:
Carmustine: 12.6 minutes, Thio Tepa:27.1 minutes
Warning: Do not use with Carmustine and Thiotepa.
Dark Blue Glove:
Chemotherapy Drugs Minimum Breakthrough Detection Time, minutes
- Bendamustine HCl, 5 mg/ml - >240 min
- Bortezomib (Velcade), 1 mg/ml - >240 min
- Busulfan, 6 mg/ml - >240 min
- Carboplatin, 10 mg/ml - >240 min
- Carmustine, 3.3 mg/ml - 11.0 min.
- Carfilzomib, 2 mg/ml - >240 min.
- Cetuximab (Erbitux), 2 mg/ml - >240 min.
- Chloroquine, 50mg/ml - >240 min.
- Cisplatin, 1 mg/ml - >240 min.
- Cladribine, 1.0 mg/ml - >240 min.
- Cyclophosphamide, 20 mg/ml - >240 min.
- Cyclosporin A,100mg/ml - >240 min.
- Cytarabine HCl, 100 mg/ml - >240 min.
- Cytovene, 10 mg/ml - >240 min.
- Dacarbazine, 10 mg/ml - >240 min.
- Daunorubicin HCl, 5 mg/ml - >240 min.
- Decitabine, 5 mg/ml - >240 min.
- Docetaxel, 10 mg/ml - >240 min.
- Doxorubicin HCl, 2 mg/ml - >240 min.
- Epirubicin HCl, 2 mg/ml - >240 min.
- Etoposide, 20 mg/ml - >240 min.
- Fludarabine Phosphate, 25 mg/ml - >240 min.
- 5-Fluorouracil, 50 mg/ml - >240 min.
- Gemcitabine HCl, 38 mg/ml - >240 min.
- Idarubicin HCl, 1 mg/ml - >240 min.
- Ifosfamide, 50 mg/ml - >240 min.
- Irinotecan HCl, 20 mg/ml - >240 min.
- Mechlorethamine HCl, 1 mg/ml - >240 min.
- Melphalan HCl, 5 mg/ml - >240 min.
- Methotrexate, 25 mg/ml - >240 min.
- Mitomycin-C, 0.5 mg/ml - >240 min.
- Mitoxantrone HCl, 2 mg/ml - >240 min.
- Oxaliplatin, 2 mg/ml - >240 min.
- Paclitaxel, 6 mg/ml - >240 min.
- Retrovir, 10 mg/ml - >240 min.
- ThioTEPA, 10 mg/ml - 26.0 min.
- Trisonex, 1 mg/ml - >240 min.
FORM FDA 3881 (8/23) Page 2 of 3 PSC Publishing Services (301) 443-6740 EF
Page 6
- Vidaza(Azacitidine),25 mg/ml - >240 min.
- Vincristine Sulfate,1 mg/ml - >240 min.
Fentanyl, Gastric Acid and Xylazine Minimum Breakthrough Detection Time
- Fentanyl Citrate Injection,50mcg/ml - >240 min.
- Gastric Acid - >240 min.
- Fentanyl Citrate: Xylazine HCl, 50:50 - >240 min.
*Please note that the following drugs have extremely low permeation times:
Carmustine: 11.0 minutes, Thio Tepa:26.0 minutes
Warning: Do not use with Carmustine and Thiotepa.
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)
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:
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"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."
FORM FDA 3881 (8/23) Page 3 of 3 PSC Publishing Services (301) 443-6740 EF
§ 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.