(98 days)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Test Chemotherapy Drug and Concentration | Average BDT |
|---|---|
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 min. |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 min. |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 min. |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 2.3 min. |
| Thiotepa, 10.0mg/ml (10,000ppm) | 30.9 min. |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 min. |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 min. |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 min. |
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 min. |
Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM standard D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Here's a breakdown of the acceptance criteria and the study information for the Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Code | LZA | LZA |
| Intended Use | Disposable non-sterile device for medical purposes, worn on hand/finger to prevent contamination. | Meets |
| Chemotherapy Drugs (Breakthrough Detection Time - BDT) | Fluorouracil, Etoposide, Cyclophosphamide, Paclitaxel, Doxorubicin HCl, Dacarbazine, Cisplatin: >240 min | Fluorouracil (50.0mg/ml): >240 min Etoposide (20.0mg/ml): >240 min Cyclophosphamide (20mg/ml): >240 min Paclitaxel (6.0mg/ml): >240 min Doxorubicin HCl (2.0mg/ml): >240 min Dacarbazine (10.0mg/ml): >240 min Cisplatin (1.0mg/ml): >240 min |
| Carmustine & Thiotepa: Permeation times should be reported. | Carmustine (3.3mg/ml): 2.3 min Thiotepa (10.0mg/ml): 30.9 min | |
| Labeling | No special labeling claims, no hypoallergenic claims. | Meets |
| Device Materials | Nitrile compound | Nitrile Compound |
| Color | Blue | Blue |
| Tensile strength (before/after aging) | ASTM D6319-10 (Meets) | Meets |
| Ultimate elongation (before/after aging) | ASTM D6319-10 (Meets) | Meets |
| Freedom from pinholes | ASTM D6319-10, ASTM D5151-06 (2011), 21CFR800.20 (Meets) | Meets |
| Dimensions (Overall length, Width, Palm, Finger thickness) | ASTM D6319-10 (Meets) | Meets |
| Residual powder | ASTM D6319-10, ASTM D6124 (Meets) | Meets |
| Primary skin irritation test | ISO 10993-10 (Not an irritant) | Not an irritant |
| Dermal sensitization assay | ISO 10993-10 (Not a sensitizer) | Not a sensitizer |
| Resistance to Permeation | ASTM D6978-05 (Specific breakthrough times for chemotherapy drugs) | Carmustine: 2.3 minutes Thiotepa: 30.9 minutes Other specified drugs: >240 minutes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the individual tests (e.g., tensile strength, pinholes, biocompatibility, resistance to permeation). However, it indicates that the device's physical and performance characteristics meet the requirements of ASTM D 6319-10 and ASTM D 6978-05, which are standards that specify testing methodologies and, implicitly, sample sizes (e.g., AQL levels for pinholes).
The data provenance is from non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The country of origin for the device manufacturer is CHINA (Hebei Province). The testing itself (e.g., ASTM standards, ISO standards) is generally applicable internationally. The document does not specify if the data is retrospective or prospective, but given it's part of a 510(k) submission, it would be considered prospective in the sense that the device was specifically tested to demonstrate compliance for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM, ISO) that yield quantitative measurements (e.g., tensile strength values, breakthrough detection times, pass/fail for pinholes, irritation/sensitization ratings). There isn't a need for expert consensus in the way there would be for image interpretation or disease diagnosis.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the acceptance criteria are based on objective measurements against established standards, not on subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret results, and the study aims to assess the impact of an AI tool on their performance. For a medical glove, performance is evaluated through physical, chemical, and biological testing as outlined above.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. The device is a physical product (a glove), not an algorithm or AI system. Its performance is inherent to the product itself, not an independent algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Standardized Test Results: Compliance with established industry standards such as ASTM D6319-10 (for physical properties like tensile strength, elongation, dimensions, freedom from holes, residual powder) and ISO 10993-10 (for biocompatibility).
- Quantitative Measurement: For chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time (BDT), determined according to ASTM D6978-05.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of the glove and its materials are designed to meet the specifications, and the testing ensures these specifications are met for production batches.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8.
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
JUL 0 8 2014
)
Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
510 (K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 8807.92. ---
The assigned 510(K) number is: K140816
l . Owner's Identification:
Ms. Zhu Chunyan Better Care Plastic Technology Co., Ltd Fugian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
Tel: 86-311-83601854 Fax: 86-311-83616934
ﺮ Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: June 18, 2014
2. Name of the Device:
Trade Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA Device Class: Class I
3. Predicate Device Information:
Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K102096)
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Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
4. Device Descrintion:
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM standard D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
5. Intended Use of the Device:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Test Chemotherapy Drug and Concentration | Average BDT |
|---|---|
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 min. |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 min. |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 min. |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 2.3 min. |
| Thiotepa, 10.0mg/ml (10,000ppm) | 30.9 min. |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 min. |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 min. |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 min. |
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 min. |
Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.
6. Technological Characteristics and Substantial Equivalence:
Better Care Plastic Technology Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) is substantially equivalent in safety and effectiveness to the Syntex Healthcare Products Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K102096). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.
And the properties between the subject device and the predicate device are compared in the following table:
| Characteristics | Standard | Device Performance | Result of comparison | |
|---|---|---|---|---|
| Predicate device | Subject Device | |||
| Product Code | / | LZA | LZA | Substantialequivalence |
| Characteristics | Standard | Device Performance | Result ofcomparison | |
| Predicate device | Subject Device | |||
| Intended Use | / | Predicate device isdisposable non-sterile deviceintended formedical purposethat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer.The average BDT fortested chemotherapydrugs of Fluorouracil,50.0mg/ml(50,000ppm),Etoposide (Toposar),20.0mg/ml(20,000ppm),Cyclophosphamide(Cytoxan), 20mg/ml(20,000ppm),Paclitaxel (Taxol),6.0mg/ml (6,000ppm),DoxorubicinHydrochloride,2.0mg/ml (2,000ppm),Dacarbazine (DTIC),10.0mg/ml(10,000ppm),Cisplatin, 1.0mg/ml(1,000ppm)is >240min, andCarmustine andThiotepa haveextremely lowpermeation times ofless than 30 minutes. | Subject device isdisposable non-sterile deviceintended formedical purposethat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer.The average BDT fortested chemotherapydrugs of Fluorouracil,50.0mg/ml(50,000ppm),Etoposide (Toposar),20.0mg/ml(20,000ppm),Cyclophosphamide(Cytoxan), 20mg/ml(20,000ppm),Paclitaxel (Taxol),6.0mg/ml (6,000ppm),DoxorubicinHydrochloride,2.0mg/ml (2,000ppm),Dacarbazine (DTIC),10.0mg/ml(10,000ppm),Cisplatin, 1.0mg/ml(1,000ppm)is >240min, andCarmustine andThiotepa haveextremely lowpermeation times of30.9 mins and2.3mins, respectively | Substantialequivalence |
| Characteristics | Standard | Device Performance | Result ofcomparison | |
| Predicate device | Subject Device | |||
| Labeling | / | There are no speciallabeling claims anddo not claim glovesas hypoallergenicon labels. | There are no speciallabeling claims anddo not claim glovesas hypoallergenicon labels. | Substantialequivalence |
| Device Materials | / | Nitrile compound | Nitrile Compound | Substantialequivalence |
| Color | / | Blue | Blue | Substantialequivalence |
| Device tolerances and specifications & Performance Data: | ||||
| Tensile strength:before and after aging | ASTMD6319-10 | Meets | Meets | Substantialequivalence |
| Ultimate elongation:before and after aging | ASTMD6319-10 | Meets | Meets | Substantialequivalence |
| Freedom frompinholes | ASTMD6319-10 | Meets | Meets | Substantialequivalence |
| Dimensions: Overalllength, Width, Palmand Finger thickness | ASTMD6319-10 | Meets | Meets | Substantialequivalence |
| Residual powder | ASTMD6319-10,ASTMD6124 | Meets | Meets | Substantialequivalence |
| Biocompatibility | ||||
| Primary skin irritationtest | ISO 10993-10 | Under conditions ofthe study, not anirritant | Under conditions ofthe study, not anirritant | Substantialequivalence |
| Dermal sensitizationassay | ISO 10993-10 | Under conditions ofthe study, not asensitizer | Under conditions ofthe study, not asensitizer | Substantialequivalence |
| Resistance to Permeation | ||||
| Resistance toPermeation | ASTMD6978-05 | Carmustine andThiotepa haveextremely lowpermeation times ofless than 30minutes. | Carmustine andThiotepa haveextremely lowpermeation times of30.9 minutes and2.3 minutes, | Substantialequivalence |
| Characteristics | Standard | Device Performance | Result ofcomparison | |
| Predicate device | Subject Device | |||
| Indication for Use | / | It is disposable non-sterile deviceintended formedical purposethat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer.The average BDT fortested chemotherapydrugs of Fluorouracil,50.0mg/ml(50,000ppm),Etoposide (Toposar),20.0mg/ml(20,000ppm),Cyclophosphamide(Cytoxan), 20mg/ml(20,000ppm),Paclitaxel (Taxol),6.0mg/ml (6,000ppm),DoxorubicinHydrochloride,2.0mg/ml (2,000ppm),Dacarbazine (DTIC),10.0mg/ml(10,000ppm),Cisplatin, 1.0mg/ml(1,000ppm)is >240min, andCarmustine andThiotepa haveextremely lowpermeation times ofless than 30 minutes. | A patientexamination gloveis disposable non-sterile deviceintended formedical purposethat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer.The average BDT fortested chemotherapydrugs of Fluorouracil,50.0mg/ml(50,000ppm),Etoposide (Toposar),20.0mg/ml(20,000ppm),Cyclophosphamide(Cytoxan), 20mg/ml(20,000ppm),Paclitaxel (Taxol),6.0mg/ml (6,000ppm),DoxorubicinHydrochloride,2.0mg/ml (2,000ppm),Dacarbazine (DTIC),10.0mg/ml(10,000ppm),Cisplatin, 1.0mg/ml(1,000ppm)is >240min, andCarmustine andThiotepa haveextremely lowpermeation times of30.9 mins and2.3mins, respectively | Substantialequivalence |
{2}------------------------------------------------
Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
,
Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) :
{3}------------------------------------------------
Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
{4}------------------------------------------------
Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy -Drugs (Blue)
ર-5
{5}------------------------------------------------
Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
Better Care Plastic Technology Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D6319-10. biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.
| Characteristics | Applicable FDA- RecognizedStandards | Performance Results |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from holes | ASTM D 6319-10ASTM D5151-06(2011)21CFR800.20 | Meets |
| Residual Powder Test | ASTM D 6319-10ASTM D6124-06(Reapproved 2011) | Meets |
| Primary Skin Irritation andSkin Sensitization | ISO 10993 Part 10 | Meets |
| Resistance to Permeation | ASTM D6978-05 | See Data in Section 18 |
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as Follows:
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing.
9. Labeling:
イ
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) with a chemotherapy claim, which are tested per ASTM D6978, and provide protection against: Fluorouracil, Etoposide (Toposar), Cyclophosphamide (Cytoxan), Paclitaxel (Taxol), Doxorubicin Hydrochloride, Dacarbazine (DTIC), Cisplatin. Do not use with Carmustine and Thiotepa. The tested chemotherapy drugs' breakthrough detection times, refer to item 5 in this summary for details.
We do not claim our gloves as hypoallergenic on our labels.
{6}------------------------------------------------
Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province, CHINA 050000
Product: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
10. Conclusions:
Better Care Plastic Technology Co., Ltd's Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) conform fully to ASTM D 6319-10 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
Drawn from the complete list of non-clinical tests, the device herein mentioned is as safe, as effective, and performs as well as the legally marketed predicate device.
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Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2014
Better Care Plastic Technology Company, Limited C/O Ms. Kathy Liu Official Correspondent Hongray USA Medical Products, Incorporated 3973 Schaefer Avenue Chino, CA 91710
Re: K140816
Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA, LZC Dated: June 4, 2014 Received: June 6, 2014
Dear Ms. Liu:
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. 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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Page 2 - Ms. Liu
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Maryner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
510(k) Number (if known) K140816
Device Name
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
Indications for Use (Describe)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Test Chemotherapy Drug and Concentration | Average BDT |
|---|---|
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 min. |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 min. |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 min. |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 2.3 min. |
| Thiotepa, 10.0mg/ml (10,000ppm) | 30.9 min. |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 min. |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 min. |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 min. |
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 min. |
Please note that Carmusine and Thiotepa have extremely low permeation times of 2.3 minutes, respectively.
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sreekanth
ly signed by Sreekanth Gutala -S
US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 3.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S 0-2014.07.07 11:46:05 -04'00'
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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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§ 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.