(102 days)
Not Found
No
The device is a physical barrier (gloves) and the description focuses on material properties and performance against standards, with no mention of AI/ML.
No
Explanation: The device is an examination glove, acting as a barrier to prevent contamination, not to treat or diagnose a medical condition.
No
Explanation: The device is described as examination gloves used to prevent contamination, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description clearly states it is a physical glove made of nitrile, intended to be worn on the hands. It is a tangible hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Function: The description clearly states that this device is a glove worn on the hands to prevent contamination between the patient and the examiner. It acts as a physical barrier.
- Lack of Diagnostic Purpose: The device does not analyze any biological samples or provide any diagnostic information about the patient's health. Its function is purely protective and preventative.
- Testing for Chemotherapy Drugs: While the gloves are tested for use with chemotherapy drugs, this testing relates to the glove's barrier properties and safety for the user and patient when handling these substances, not for diagnosing or monitoring a condition in the patient.
The device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Powder Free Blue Nitrile Examination 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 |
|---|---|---|
| Bleomycin | 15 mg/ml (15,000 ppm) | >240 |
| Busulfan | 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300ppm) | 8.5 (12.7, 13.4, 8.5) |
| Cisplatin | 1.0 mg/ml (1,000ppm) | >240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml (20,000ppm) | >240 |
| Cytarabine | 100 mg/ml (100,000ppm) | >240 |
| Cytovene | 10 mg/ml (10,000ppm) | >240 |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 |
| Daunorubicin | 5 mg/ml (5,000ppm) | >240 |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000ppm) | >240 |
| Ellence | 2 mg/ml (2,000ppm) | >240 |
| Etoposide(Toposar) | 20.0 mg/ml(20,000ppm) | >240 |
| Fludarabine | 25 mg/ml(25,000ppm) | >240 |
| Fluorouracil | 50 mg/ml(50,000ppm) | >240 |
| Gemcitabine (Gemzar) | 38 mg/ml(38,000ppm) | >240 |
| Idarubicin | 1 mg/ml (1,000ppm) | >240 |
| Ifosfamide | 50.0 mg/ml (50,000ppm) | >240 |
| Irinotecan | 20.0 mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI | 1.0 mg/ml (1,000ppm) | >240 |
| Melphalan | 5 mg/ml (5,000ppm) | >240 |
| Methotrexate | 25mg/ml (25,000ppm) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone | 2.0 mg/ml(2,000ppm) | >240 |
| Oxaliplatin | 2.0 mg/ml(2,000ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000ppm) | >240 |
| Rituximab | 10 mg/ml(10,000ppm) | >240 |
| Thiotepa | 10.0 mg/ml (10,000ppm) | 36.1 (51.2, 36.1, 45.6) |
| Trisenox | 0.1 mg/ml (100ppm) | >240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000ppm) | >240 |
| Vinorelbine | 10 mg/ml(10,000ppm) | >240 |
Product codes
LZA, LZC
Device Description
The proposed device, Powder Free Blue Nitrile Examination 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.
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 / Not Found
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. 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.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Hebei Titans Hongsen Medical Technology Co., LTD. % Ray Wang General Manager Beijing Believe-Med Technology Services Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 Cn
Re: K181130
Trade/Device Name: Powder Free Blue Nitrile Examination 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: July 16, 2018 Received: July 20, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -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) K181130
Device Name
Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Powder Free Blue Nitrile Examination 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 |
|---|---|---|
| Bleomycin | 15 mg/ml (15,000 ppm) | >240 |
| Busulfan | 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300ppm) | 8.5 (12.7, 13.4, 8.5) |
| Cisplatin | 1.0 mg/ml (1,000ppm) | >240 |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml (20,000ppm) | >240 |
| Cytarabine | 100 mg/ml (100,000ppm) | >240 |
| Cytovene | 10 mg/ml (10,000ppm) | >240 |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 |
| Daunorubicin | 5 mg/ml (5,000ppm) | >240 |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000ppm) | >240 |
| Ellence | 2 mg/ml (2,000ppm) | >240 |
| Etoposide(Toposar) | 20.0 mg/ml(20,000ppm) | >240 |
| Fludarabine | 25 mg/ml(25,000ppm) | >240 |
| Fluorouracil | 50 mg/ml(50,000ppm) | >240 |
| Gemcitabine (Gemzar) | 38 mg/ml(38,000ppm) | >240 |
| Idarubicin | 1 mg/ml (1,000ppm) | >240 |
| Ifosfamide | 50.0 mg/ml (50,000ppm) | >240 |
| Irinotecan | 20.0 mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI | 1.0 mg/ml (1,000ppm) | >240 |
| Melphalan | 5 mg/ml (5,000ppm) | >240 |
| Methotrexate | 25mg/ml (25,000ppm) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone | 2.0 mg/ml(2,000ppm) | >240 |
| Oxaliplatin | 2.0 mg/ml(2,000ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000ppm) | >240 |
| Rituximab | 10 mg/ml(10,000ppm) | >240 |
| Thiotepa | 10.0 mg/ml (10,000ppm) | 36.1 (51.2, 36.1, 45.6) |
| Trisenox | 0.1 mg/ml (100ppm) | >240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000ppm) | >240 |
| Vinorelbine | 10 mg/ml(10,000ppm) | >240 |
*Please note that the following drugs have low permeation times:
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Type of Use (Select one or both, as applicable)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and 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) is being submitted in accordance with 21 CFR 807.92.
The assigned 510(k) Number: K181130
-
- Date of Preparation: 08/03/2018
-
- Sponsor Identification
HEBEI TITANS HONGSEN MEDICAL 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 3.
Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558, Fax: +86-10-56335780 Email: Ray.Wang@believe-med.com
5
4. Proposed Device Identification
Trade Name: Powder Free Blue Nitrile Examination 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 Examination 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
| Detection Time in Minutes | Concentration | Breakthrough Minutes |
|---|---|---|
| Bleomycin | 15 mg/ml (15,000 ppm) | >240 |
| Busulfan | 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300ppm) | 8.5 |
| Cisplatin | 1.0 mg/ml (1,000ppm) | (12.7,13.4, 8.5) |
| Cyclophosphamide(Cytoxan) | 20.0 mg/ml (20,000ppm) | >240 |
| Cytarabine | 100 mg/ml (100,000ppm) | >240 |
| Cytovene | 10 mg/ml (10,000ppm) | >240 |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 |
| Daunorubicin | 5 mg/ml (5,000ppm) | >240 |
| Docetaxel | 10.0 mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000ppm) | >240 |
| Ellence | 2 mg/ml (2,000ppm) | >240 |
| Etoposide(Toposar) | 20.0 mg/ml(20,000ppm) | >240 |
| Fludarabine | 25 mg/ml(25,000ppm) | >240 |
| Fluorouracil | 50 mg/ml(50,000ppm) | >240 |
| Gemcitabine (Gemzar) | 38 mg/ml(38,000ppm) | >240 |
| Idarubicin | 1 mg/ml (1,000ppm) | >240 |
| Ifosfamide | 50.0 mg/ml (50,000ppm) | >240 |
| Irinotecan | 20.0 mg/ml (20,000ppm) | >240 |
6
| Mechlorethamine HCI | 1.0 mg/ml (1,000ppm) | >240 |
|---|---|---|
| Melphalan | 5 mg/ml (5,000ppm) | >240 |
| Methotrexate | 25mg/ml (25,000ppm) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone | 2.0 mg/ml(2,000ppm) | >240 |
| Oxaliplatin | 2.0 mg/ml(2,000ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000ppm) | >240 |
| Rituximab | 10 mg/ml(10,000ppm) | >240 |
| Thiotepa | 10.0 mg/ml (10,000ppm) | 36.1 |
| (51.2,36.1, 45.6) | ||
| Trisenox | 0.1 mg/ml (100ppm) | >240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000ppm) | >240 |
| Vinorelbine | 10 mg/ml(10,000ppm) | >240 |
*Please note that the following drugs have low permeation times: Carmustine (BCNU): 8.5 minutes and Thiotepa: 36.1 minutes
5. Predicate Device Identification
510(k) Number: K163146
Product Name: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD.
- Device Description 6.
The proposed device, Powder Free Blue Nitrile Examination 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.
7
7. Technological Comparison Tables
| Item | Proposed Device (K181130) | Predicate Device (K163146) | Remark |
|---|---|---|---|
| Product Code | LZA, LZC | LZA, LZC | SAME |
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended use | The Powder Free Blue Nitrile | ||
| Examination 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 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. | SAME | ||
| Design Feature | ambidextrous | ambidextrous | SAME |
| 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 | ||
| Chemotherapy | |||
| Drug | |||
| Permeation | |||
| Claim | Bleomycin, Busulfan, | ||
| Carboplatin, Carmustine | |||
| (BCNU), Cisplatin, | |||
| Cyclophosphamide(Cytoxan), | |||
| Cytarabine, Cytovene, | |||
| Dacarbazine(DTIC) , | |||
| Daunorubicin, Docetaxel, | |||
| Doxorubicin, Hydrochloride, | |||
| Ellence, toposide(Toposar), | |||
| Fludarabine, Fluorouracil, | |||
| Gemcitabine (Gemzar), | |||
| Idarubicin, Ifosfamide, | |||
| Irinotecan, Mechlorethamine | |||
| HCI, Melphalan, | |||
| Methotrexate, Mitomycin C, | |||
| Mitoxantrone, Oxaliplatin, | |||
| Paclitaxel (Taxol), Rituximab, | |||
| Thiotepa, Trisenox, | |||
| Vincristine Sulfate, | 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 | Different |
Table 1 General Comparison
8
| Proposed Device (K181130) | Designati
on | Size | | | | Tolerance | |
|----------------------------|-----------------|------|-----|-----|-----|-----------|-----------|
| | | XS | S | M | L | XL | |
| | Length,
mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width,
mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.07 | | | | ±0.02 | |
| | Palm | 0.05 | | | | min | |
| | Cuff | 0.05 | | | | ±0.02 | |
| Predicate Device (K163146) | Designati
on | Size | | | | | Tolerance |
| | | XS | S | M | L | XL | |
| | Length,
mm | 230 | 230 | 230 | 230 | 230 | min |
| | Width,
mm | 70 | 80 | 95 | 110 | 120 | ±10 |
| | Thickness, mm: | | | | | | |
| | Finger | 0.10 | | | | ±0.03 | |
| | Palm | 0.08 | | | | ±0.03 | |
| | Cuff | 0.06 | | | | ±0.03 | |
| Remark | Different | | | | | | |
Table 2 Device Dimensions Comparison
Table 3 Performance Comparison
| Item | | | Proposed Device (K181130) | Predicate Device
(K163146) | Remark |
|------------------------|-----------------|------------------------|---------------------------|-------------------------------|---------|
| Colorant | | | Blue | Blue | Similar |
| Physical
properties | Before
Aging | Tensile
Strength | 15 Mpa, min | 15 Mpa, min | SAME |
| | | Ultimate
Elongation | 500% min | 500% min | |
| | After
Aging | Tensile
Strength | 14 MPa, min | 14 MPa, min | |
9
| | Ultimate
Elongation | 400% min | 400% min | |
|--------------------|------------------------|------------------------------------------------|---------------------------------------------------|-----------|
| | Comply with ASTM D6319 | | Comply with ASTM
D6319 | SAME |
| Detection of Holes | | Not detected, in accordance with
ASTM D5151 | Not detected, in
accordance with
ASTM D5151 | SAME |
| Powder Content | | Max. 0.35 mg per glove | Max. 0.32 mg per
glove | Different |
Table 4 Safety Comparison
| Item | | Proposed Device
(K181130) | Predicate Device (K163146) | Remark |
|------------------|--------------------------|-----------------------------------------------------------|--------------------------------------------------------|---------|
| Material | | Nitrile | Nitrile | SAME |
| | Irritation | Under the conditions
of the study, not an
irritant | Under the conditions of the study,
not an irritant | |
| Biocompatibility | Sensitization | Under the conditions
of the study, not a
sensitizer | Under the conditions of the study,
not a sensitizer | Similar |
| | In Vitro
Cytotoxicity | Under the conditions
of the study, not
cytotoxic | / | |
Different Analysis:
- The proposed device has different chemotherapy drug permeation claim to the predicate device.
The chemotherapy drug permeation results for the proposed device meets the specifications of ASTM D6978 except for Carmustine and Thiotepa.
-
The proposed device has different thickness specification to the predicate device, but all thickness of proposed devices meets the specifications of ASTM D 6319.
-
The proposed device has different powder content to the predicate device, but all powder content of proposed devices meets the specifications of ASTM D 6319.
8. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all specifications. The test results demonstrated that the proposed device complies with the following standards:
- ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical ●
10
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.
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Comparison Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
- Comparison Conclusion