(96 days)
The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The proposed device, POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes
The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.
The document provided is a 510(k) premarket notification for "POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria, statistical analysis, and expert ground truth consensus typical for AI-powered diagnostic devices.
Therefore, the requested information about acceptance criteria, efficacy study design, sample sizes for test and training sets, expert qualifications, and adjudication methods (sections 1-9 of your prompt) does not directly apply in the context of this 510(k) submission for medical gloves.
The "study" in this context refers to bench testing against established industry standards for medical gloves, and the "acceptance criteria" are the performance specifications outlined in those standards.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
The acceptance criteria are derived from various ASTM and ISO standards for medical gloves. The reported device performance indicates compliance with these standards.
| Acceptance Criterion (from relevant standard) | Reported Device Performance |
|---|---|
| Chemotherapy Drug Permeation (ASTM D6978-05) | |
| Fluorouracil: Breakthrough Detection Time | > 240 minutes |
| Etoposide (Toposar): Breakthrough Detection Time | > 240 minutes |
| Cyclophosphamid (Cytoxan): Breakthrough Detection Time | > 240 minutes |
| Carmustine (BCNU): Breakthrough Detection Time | 45.0 minutes |
| Thiotepa: Breakthrough Detection Time | 30.0 minutes |
| Paclitaxel (Taxol): Breakthrough Detection Time | > 240 minutes |
| Doxorubicin Hydrochloride: Breakthrough Detection Time | > 240 minutes |
| Dacarbazine (DTIC): Breakthrough Detection Time | > 240 minutes |
| Cisplatin: Breakthrough Detection Time | > 240 minutes |
| Carboplatin: Breakthrough Detection Time | > 240 minutes |
| Docetaxel: Breakthrough Detection Time | > 240 minutes |
| Ifosfamide: Breakthrough Detection Time | > 240 minutes |
| Irinotecan: Breakthrough Detection Time | > 240 minutes |
| Mechlorethamine HCL: Breakthrough Detection Time | > 240 minutes |
| Methotrexate: Breakthrough Detection Time | > 240 minutes |
| Mitomycin C: Breakthrough Detection Time | > 240 minutes |
| Mitoxantrone: Breakthrough Detection Time | > 240 minutes |
| Vincristine Sulfate: Breakthrough Detection Time | > 240 minutes |
| Physical Properties - Before Aging (ASTM D6319-10) | |
| Tensile Strength | 15 Mpa, min |
| Ultimate Elongation | 500% min |
| Physical Properties - After Aging (ASTM D6319-10) | |
| Tensile Strength | 14 MPa, min |
| Ultimate Elongation | 400% min |
| Freedom from Holes (ASTM D5151-06) | Free from holes, AQL 1.5 |
| Powder Content (ASTM D6124-06) | Max. 0.32 mg per glove |
| Biocompatibility - Irritation (ISO 10993-10) | Not an irritant |
| Biocompatibility - Sensitization (ISO 10993-10) | Not a sensitizer |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test within the standards (e.g., how many gloves were tested for permeation, holes, etc.). However, it refers to standards like ISO 2859-1:1999 ("Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection"), which would dictate the sample sizes used for quality control aspects like freedom from holes.
The data provenance is from bench testing conducted by the manufacturer, Hebei Hongsen Plastics Technology Co., Ltd. The country of origin for the manufacturing and testing data would be China, as indicated by the manufacturer's address. This is retrospective testing performed to demonstrate compliance for a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For medical gloves, "ground truth" is established by adherence to physical, chemical, and biological performance standards, not by expert consensus on clinical data interpretation. The tests are objective measurements (e.g., breakthrough time, tensile strength, presence of holes).
4. Adjudication method for the test set
Not applicable. The tests are objective measurements according to standardized protocols, eliminating the need for adjudication among human readers.
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 a medical glove, not an AI-powered diagnostic device. No human-in-the-loop performance or AI assistance considerations are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical glove.
7. The type of ground truth used
The "ground truth" for the device's performance is established by objective measurements and adherence to performance specifications defined in international and national standards, such as:
- Physical properties (tensile strength, elongation)
- Dimensional properties (length, width, thickness)
- Freedom from holes
- Chemical permeation (chemotherapy drugs)
- Biological safety (irritation, sensitization)
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device. The manufacturing process is designed to produce gloves meeting specifications, and the testing confirms this.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized depiction of three human profiles facing to the right, layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2017
Hebei Hongsen Plastics Technology Co, Ltd % Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd.,liyuan, Tongzhou District Beijing, 101121 CN
Re: K163146 Trade/Device Name: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: January 3. 2017 Received: January 9, 2017
Dear Ray Wang:
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.
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
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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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D.
Acting 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
Indications for Use
510(k) Number (if known) K163146
Device Name
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
| The following chemicals have been tested with proposed device. | ||
|---|---|---|
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | > 240 |
| Cyclophosphamid (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 |
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 45.0 |
| *Thiotepa | 10.0 mg/ml (10,000 ppm) | 30.0 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | > 240 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 |
| Carboplatin | 10.0 mg/ml (10,000 ppm) | > 240 |
| Docetaxel | 10.0 mg/ml (10,000 ppm) | > 240 |
| Ifosfamide | 50.0 mg/ml (50,000 ppm) | > 240 |
| Irinotecan | 20.0 mg/ml (20,000 ppm) | > 240 |
| Mechlorethamine HCL | 1.0 mg/ml (1,000 ppm) | > 240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm) | > 240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 |
- Please note that the following drugs have low permeation times: Carmustine (BCNU): 45 minutes and Thiotepa: 30 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K163146
-
- Date of Preparation: 02/08/2017
-
- Sponsor Identification
HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD EASTERN INDUSTRIAL ZONE, NANGONG CITY, HEBEI PROVINCE, CHINA
Contact Person: Mr. ShaoZhang Nan Tel: +86-0319-7295820 Fax: +86-0319-7295801 Email: nanshaozhang@163.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China
Tel: +86-21-59120817 Fax: +86-21-59120817 Email: Ray.Wang@believe-med.com
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4. Proposed Device Identification
Trade Name: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs Device Name: NITRILE Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves
Regulatory Information
Classification: I Product Code: LZA, LZC Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
Indication for Use:
The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with proposed device.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | > 240 |
| Cyclophosphamid (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 |
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 45.0 |
| *Thiotepa | 10.0 mg/ml (10,000 ppm) | 30.0 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | > 240 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 |
| Carboplatin | 10.0 mg/ml (10,000 ppm) | > 240 |
| Docetaxel | 10.0 mg/ml (10,000 ppm) | > 240 |
| Ifosfamide | 50.0 mg/ml (50,000 ppm) | > 240 |
| Irinotecan | 20.0 mg/ml (20,000 ppm) | > 240 |
| Mechlorethamine HCL | 1.0 mg/ml (1,000 ppm) | > 240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm) | > 240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 |
*Please note that the following drugs have low permeation times:
Carmustine (BCNU): 45 minutes and Thiotepa: 30 minutes
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-
- Predicate Device Identification
510(k) Number: K141982
- Predicate Device Identification
Product Name: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs
Manufacturer: WRP Asia Pacific Sdn Bhd.
- Device Description 6.
The proposed device, POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes
The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.
The proposed device was tested according to the following standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05. These standards are identified in the following section "Non-clinical test conclusion.
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all specifications and the proposed device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.
ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs
ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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| Item | Proposed DevicePOWDER FREE Blue NitrileGLOVES, Tested for Use withChemotherapy Drugs(K163146) | Predicate DeviceDermagrip Powder Free Blue NitrilePatient Examination Gloves Tested forUse with Chemotherapy Drugs(K141982) | Remark | Size | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Product Code | LZA, LZC | LZA, LZC | Same | Proposed Device | Designation | XS | S | M | L | XL | Tolerance | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | POWDER FREE Blue Nitrile GLOVES, Tested for Usewith Chemotherapy Drugs(K163146) | Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Class | I | I | Same | Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | ||
| Indication for use | The POWDER FREE Blue NitrileGLOVES, Tested for Use withChemotherapy Drugs is a disposabledevice intended for medical purposesthat is worn on the examiner's handsto prevent contamination betweenpatient and examiner. | A patient examination glove is adisposable device intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer. | Same | Thickness, mm: | ||||||||
| Powdered orPowered free | Powdered free | Powdered free | Same | Finger | 0.10 | ±0.03 | ||||||
| Design Feature | ambidextrous | ambidextrous | Same | Palm | 0.08 | ±0.03 | ||||||
| LabelingInformation | Single-use indication, powder free,device name, glove size and quantity,Nitrile Examination Gloves,Non-Sterile | Single-use indication, powder free,device name, glove size and quantity,Nitrile Examination Gloves,Non-Sterile | Same | Cuff | 0.06 | ±0.03 | ||||||
| Chemotherapy DrugPermeation Claim | Fluorouracil, Etoposide (Toposar),Cyclophosphamid (Cytoxan),Carmustine (BCNU), Thiotepa,Paclitaxel (Taxol), DoxorubicinHydrochloride, Dacarbazine (DTIC),Cisplatin, Carboplatin, Docetaxel,Ifosfamide, Irinotecan,Mechlorethamine HCL,Methotrexate, Mitomycin C,Mitoxantrone, Vincristine Sulfate | Fluorouracil, Etoposide (Toposar),Cyclophosphamid (Cytoxan),Carmustine (BCNU), Thiotepa,Paclitaxel (Taxol), DoxorubicinHydrochloride, Dacarbazine (DTIC),Cisplatin, Ifosfamide, Mitoxantrone,Vincristine Sulfate | Analysis 1 | Predicate Device | Size: Min. 240 mm | |||||||
| Dermagrip Powder Free Blue Nitrile PatientExamination Gloves Tested for Use with ChemotherapyDrugs(K141982) | Thickness: Finger (0.07-0.10); Palm(0.07-0.09); Cuff (0.06-0.08) | |||||||||||
| Remark | Analysis 2 |
8. Substantially Equivalent (SE) Comparison Conclusion
Table 1 General Comparison
Analysis 1:
The proposed and predicate devices both have a tested for use with chemotherapy drugs claim. However, different chemotherapy drugs have been tested for the proposed device and the results meet the specifications of ASTM D6978
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Table 2 Device Dimensions Comparison
Analysis 2:
The proposed device has different size specification as compared to the predicate device, but the proposed device meets the specifications of ASTM D6319.
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| Item | Proposed DevicePOWDER FREE Blue Nitrile GLOVES,Tested for Use with Chemotherapy Drugs(K163146) | Predicate DeviceDermagrip Powder FreeBlue Nitrile PatientExamination Gloves Testedfor Use with ChemotherapyDrugs(K141982) | Remark | ||
|---|---|---|---|---|---|
| Colorant | Blue | Blue | Same | ||
| Physicalproperties | BeforeAging | TensileStrength | 15 Mpa, min | Meet the Requirements ofASTM D 6319 | Analysis 3 |
| UltimateElongation | 500% min | Meet the Requirements ofASTM D 6319 | |||
| AfterAging | TensileStrength | 14 MPa, min | Meet the Requirements ofASTM D 6319 | ||
| UltimateElongation | 400% min | Meet the Requirements ofASTM D 6319 | |||
| Comply with ASTM D6319 | Comply with ASTM D631914 MPa. Min/500% min.before aging;14 MPa. Min./400% min.After aging | Same | |||
| Freedom from Holes | Be free from holes when tested inaccordance with ASTM D5151AQL 1.5 | Be free from holes whentested in accordance withASTM D5151under AQL 2.5/InspectionLevel G-I | Same | ||
| Powder Content | Max. 0.32 mg per glove | Meet the requirements ofASTM D6319Less than 2mg per glove | Same |
Table 3 Performance Comparison
Analysis 3:
The proposed device has a different Ultimate Elongation after aging as compared to the predicate device, but the proposed device meets the specifications of ASTM D6319.
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| Item | Proposed DevicePOWDER FREE BlueNitrile GLOVES, Tested forUse with ChemotherapyDrugs(K163146) | Predicate DeviceDermagrip Powder Free Blue NitrilePatient Examination Gloves Tested for Usewith Chemotherapy Drugs(K141982) | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation | Under the conditions of thestudy, not an irritant | Comply with ISO 10993-10 | Same |
| Sensitization | Under the conditions of thestudy, not a sensitizer | |||
| Label and Labeling | Meet FDA'sRecommendations | Meet FDA's Recommendations | Same |
Table 4 Safety Comparison
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device, POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Tested for Use with Chemotherapy Drugs.
§ 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.