(96 days)
Not Found
No
The document describes a physical medical device (gloves) and its performance testing against established standards, with no mention of AI or ML technology.
No
The device is a glove intended to prevent contamination, functioning as a barrier, not to treat or cure a disease or condition.
No
The device is a glove intended to prevent contamination between patient and examiner, acting as a barrier. It does not provide any diagnosis of a disease or condition.
No
The device is a physical glove made of nitrile, intended to be worn on the hands. It is a tangible hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a disposable device worn on the examiner's hands to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic one.
- Device Description: The description reinforces the barrier function and mentions it's a patient examination glove.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) to provide information about a person's health, diagnose a condition, or monitor treatment.
- Testing: The testing mentioned (ASTM D6978-05) is related to the glove's barrier properties against chemotherapy drugs, not diagnostic performance.
- No Mention of Diagnostic Metrics: There are no mentions of metrics typically associated with diagnostic devices like sensitivity, specificity, PPV, NPV, etc.
Therefore, this device falls under the category of a medical device with a barrier function, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / medical purposes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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.
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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
4
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
5
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
6
-
- 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.
7
| Item | Proposed Device
POWDER FREE Blue Nitrile
GLOVES, Tested for Use with
Chemotherapy Drugs
(K163146) | Predicate Device
Dermagrip Powder Free Blue Nitrile
Patient Examination Gloves Tested for
Use 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 Use
with 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 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. | A patient examination glove is a
disposable device intended for medical
purposes that is worn on the
examiner's hand to prevent
contamination between patient and
examiner. | Same | | Thickness, mm: | | | | | | | |
| Powdered or
Powered free | Powdered free | Powdered free | Same | | Finger | | 0.10 | | | | | ±0.03 |
| Design Feature | ambidextrous | ambidextrous | Same | | Palm | | 0.08 | | | | | ±0.03 |
| Labeling
Information | 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 Drug
Permeation Claim | Fluorouracil, Etoposide (Toposar),
Cyclophosphamid (Cytoxan),
Carmustine (BCNU), Thiotepa,
Paclitaxel (Taxol), Doxorubicin
Hydrochloride, 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), Doxorubicin
Hydrochloride, Dacarbazine (DTIC),
Cisplatin, Ifosfamide, Mitoxantrone,
Vincristine Sulfate | Analysis 1 | Predicate Device | Size: Min. 240 mm | | | | | | | |
| Dermagrip Powder Free Blue Nitrile Patient
Examination Gloves Tested for Use with Chemotherapy
Drugs
(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
8
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.
9
| Item | | | Proposed Device
POWDER FREE Blue Nitrile GLOVES,
Tested for Use with Chemotherapy Drugs
(K163146) | Predicate Device
Dermagrip Powder Free
Blue Nitrile Patient
Examination Gloves Tested
for Use with Chemotherapy
Drugs
(K141982) | Remark |
|------------------------|-----------------|------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Colorant | | | Blue | Blue | Same |
| Physical
properties | Before
Aging | Tensile
Strength | 15 Mpa, min | Meet the Requirements of
ASTM D 6319 | Analysis 3 |
| | | Ultimate
Elongation | 500% min | Meet the Requirements of
ASTM D 6319 | |
| | After
Aging | Tensile
Strength | 14 MPa, min | Meet the Requirements of
ASTM D 6319 | |
| | | Ultimate
Elongation | 400% min | Meet the Requirements of
ASTM D 6319 | |
| | | | Comply with ASTM D6319 | Comply with ASTM D6319
14 MPa. Min/500% min.
before aging;
14 MPa. Min./400% min.
After aging | Same |
| Freedom from Holes | | | Be free from holes when tested in
accordance with ASTM D5151
AQL 1.5 | Be free from holes when
tested in accordance with
ASTM D5151
under AQL 2.5/Inspection
Level G-I | Same |
| Powder Content | | | Max. 0.32 mg per glove | Meet the requirements of
ASTM D6319
Less 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.
10
| Item | Proposed Device
POWDER FREE Blue
Nitrile GLOVES, Tested for
Use with Chemotherapy
Drugs
(K163146) | Predicate Device
Dermagrip Powder Free Blue Nitrile
Patient Examination Gloves Tested for Use
with Chemotherapy Drugs
(K141982) | Remark | |
|--------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------|
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation | Under the conditions of the
study, not an irritant | Comply with ISO 10993-10 | Same |
| | Sensitization | Under the conditions of the
study, not a sensitizer | | |
| Label and Labeling | Meet FDA's
Recommendations | 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.