(97 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML technologies.
No.
The device description states its purpose is to prevent contamination, and its performance studies focus on physical properties and barrier functions, not on treating a medical condition.
No
The document describes patient examination gloves, which are used to prevent contamination between the patient and examiner, not to diagnose a condition.
No
The device is a physical medical device (gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "patient examination glove" intended to be worn on the hand or fingers to "prevent contamination between patient and examiner." While it's tested for chemotherapy drug permeation, its primary function is a physical barrier.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. It is a physical barrier used during an examination.
- Performance Studies: The performance studies focus on the physical properties of the glove (strength, holes, dimensions) and its ability to resist permeation by chemotherapy drugs. These are not diagnostic tests performed on patient samples.
The testing for chemotherapy drug permeation is a safety feature related to the glove's use in a medical setting, not a diagnostic function.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.4 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Epirubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Gemcitabine | 38.0 mg/ml(38,000 ppm) | > 240 Minutes |
| Ifosfamide | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Irinotecan | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 Minutes |
| Miromycin C | 0.5 mg/ml(500 ppm) | > 240 Minutes |
| Mitoxantrone | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Oxaliplatin | 5.0 mg/ml(5,000 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 98.6 Minutes |
| Vincristine Sulface | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 3.3 mg/ml 16.4 Minutes Thio Tepa 10.0 mg/ml 98.6 Minutes
Warning: Please do not use with Carmustine (BCNU).
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
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)
Biocompatibility Testing
Study Type: Non-Clinical Testing
Sample Size: Not specified
Key Results:
- ISO 10993-10:2010 Tests For Irritation And Skin Sensitization: Pass (non-irritant, non-sensitizer)
- ISO 10993-5:2009 Tests For In Vitro Cytotoxicity: Pass (non-toxicity)
Performance Testing (Bench)
Study Type: Non-Clinical Testing
Sample Size: Not specified
Key Results:
- ASTM D6124-06 (Reapproved 2017) for Residual Powder on Medical Gloves: Pass (S:0.02, M:0.12, L:0.16, XL:0.14 mg/glove, all ≤ 2 mg/glove)
- ASTMD5151-19 for Detection of Holes in Medical Gloves: Pass (0/125 leaks for S, M, L, XL sizes, meeting AQL 2.5)
- ASTM D5250-19 for physical dimensions: Pass (Length, Width, Thickness comply with ASTM D6319-19 requirements)
- ASTM D412-06a-2013 for physical properties: Pass (Tensile Strength and Ultimate Elongation before and after aging comply with ASTM D6319-19 requirements)
- ASTM D6978-05 (Reapproved 2019) for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Permeation testing conducted, breakthrough times listed for various chemotherapy drugs. Carmustine (BCNU) had a breakthrough time of 16.4 minutes, ThioTepa had 98.6 minutes. Warning not to use with Carmustine (BCNU).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. However, the following physical properties and breakthrough detection times are provided:
Physical Properties:
- Powder Content: S:0.02, M:0.12, L:0.16, XL:0.14 mg/glove
- Freedom from Holes: S:0/125 leaks, M: 0/125 leaks, L: 0/125 leaks, XL: 0/125 leaks
- Dimensions - Length: >230 mm (for M/L/XL), >220 mm (for S)
- Dimensions - Width: S: 88mm; M: 98-99mm; L: 110-112mm; XL: 115-117mm
- Dimensions - Thickness: Finger: 0.101-0.128mm; Palm: 0.067-0.78mm
- Physical Properties - Tensile Strength: Before Aging: 25.4-36.3 MPa; After Aging: 25.8-35.6 MPa
- Physical Properties - Elongation: Before Aging: 508%-563%; After Aging: 483%-525%
Chemotherapy Drug Permeation Breakthrough Detection Time in Minutes:
- Carboplatin: > 240
- Carmustine (BCNU): 16.4
- Cisplatin: > 240
- Cyclophosphamide: > 240
- Dacarbazine: > 240
- Docetaxel: > 240
- Doxorubicin HCI: > 240
- Epirubicin HCI: > 240
- Etoposide: > 240
- Fluorouracil: > 240
- Gemcitabine: > 240
- Ifosfamide: > 240
- Irinotecan: > 240
- Methotrexate: > 240
- Miromycin C: > 240
- Mitoxantrone: > 240
- Oxaliplatin: > 240
- Paclitaxel: > 240
- ThioTepa: 98.6
- Vincristine Sulface: > 240
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
October 5, 2021
Jiangsu Yanfang Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 East Lujiazui Rd.,Pudong Shanghai. 200120 China
Re: K212036
Trade/Device Name: Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: August 25, 2021 Received: August 31, 2021
Dear Boyle 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/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212036
Device Name
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.4 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Epirubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Gemcitabine | 38.0 mg/ml(38,000 ppm) | > 240 Minutes |
| Ifosfamide | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Irinotecan | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 Minutes |
| Miromycin C | 0.5 mg/ml(500 ppm) | > 240 Minutes |
| Mitoxantrone | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Oxaliplatin | 5.0 mg/ml(5,000 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 98.6 Minutes |
| Vincristine Sulface | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: Carmustine (BCNU) 3.3 mg/ml 16.4 Minutes Thio Tepa 10.0 mg/ml 98.6 Minutes
Thio Tepa 10.0 mg/ml 98.0 Minutes
VIII in Plasma at -19C
Warning: Please do not use with Carmustine (BCNU).
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.
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 Drug 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 (K212036)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Jiangsu Yanfang Medical Technology Co., Ltd. Name: Address: No.16, Kaiyuan Road, Changjing Town, Jiangyin, Wuxi, Jiangsu, China 214411. Contact: Kaijian Wei Date of Preparation: Oct.05,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Nitrile Powder Free Examination Gloves, Trade name: Tested For Use With Chemotherapy Drugs Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL
3.0 Classification
Production code: LZA,LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Ever Growth (Vietnam) Co., Ltd. Device: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs 510(k) number: K190736
5
5.0 Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.
6.0 Indication for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs
| Chemotherapy Drug | Concentration | Breakthrough Detection
Time in Minutes |
|-------------------------------|------------------------|-------------------------------------------|
| Carboplatin | 10.0 mg/ml(10,000 ppm) | > 240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 16.4 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine | 10.0 mg/ml(10,000 ppm) | > 240 |
| Docetaxel | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 |
| Epirubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Gemcitabine | 38.0 mg/ml(38,000 ppm) | > 240 |
| Ifosfamide | 50.0 mg/ml(50,000 ppm) | > 240 |
| Irinotecan | 20.0 mg/ml(20,000 ppm) | > 240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 |
| Miromycin C | 0.5 mg/ml(500 ppm) | > 240 |
| Mitoxantrone | 2.0 mg/ml(2,000 ppm) | > 240 |
| Oxaliplatin | 5.0 mg/ml(5,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 98.6 |
| Vincristine Sulface | 1.0 mg/ml(1,000 ppm) | > 240 |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
6
Carmustine (BCNU) 3.3 mg/ml 16.4 Minutes Thio Tepa 10.0 mg/ml 98.6 Minutes Warning: Please do not use with Carmustine (BCNU).
7.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | LZA,LZC | LZA,LZC | Same |
| 510(k) Reference | K212036 | K190736 | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterile vs Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Color | Blue | Blue | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity,Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results. | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results. | Similar |
| Dimensions - Length | Complies with ASTM | Complies with ASTM D6319- | Similar |
| D6319-19: | 19: ≥230 mm. | ||
| S: ≥220 mm; | |||
| M/L/XL: ≥230 mm. | ≥230 mm. | ||
| Dimensions - Width | Complies with ASTM D6319-19: | ||
| S:80±10mm; | |||
| M:95±10mm; | |||
| L: 110±10mm; | |||
| XL: 120±10mm; | Complies with ASTM D6319-19: | ||
| XS: 70±10mm; | |||
| S:80±10mm; | |||
| M:95±10mm; | |||
| L: 110±10mm; | |||
| XL: 120±10mm; | Similar | ||
| Dimensions - Thickness | Complies with ASTM D6319-19 | ||
| Palm:≥0.05mm | |||
| Finger: ≥0.05mm | Complies with ASTM D6319-19 | ||
| Palm:≥0.05mm | |||
| Finger: ≥0.05mm | Same | ||
| Physical Properties - Tensile Strength | Complies with ASTM D6319-19: | ||
| Before Aging: ≥14MPa | |||
| After Aging: ≥500% | Complies with ASTM D6319-19: | ||
| Before Aging: ≥14MPa | |||
| After Aging: ≥500% | Same | ||
| Physical Properties - Elongation | Complies with ASTM D6319-19: | ||
| Before Aging: ≥14MPa | |||
| After Aging: ≥400% | Complies with ASTM D6319-19: | ||
| Before Aging: ≥14MPa | |||
| After Aging: ≥400% | Same | ||
| Freedom from Holes | Complies with ASTM D6319-19 | ||
| and ASTM D5151-19 | |||
| G-1, AQL 2.5 | Complies with ASTM D6319-19 | ||
| and ASTM D5151-19 | |||
| G-1, AQL 2.5 | Same | ||
| Powder Content | Complies with ASTM D6319-19, 240 | Different | |
| Busulfan 6.0 mg/ml | Not tested | > 240 | Different |
| Carboplatin 10.0 mg/ml | > 240 | > 240 | Same |
| Carmustine (BCNU), 3.3 mg/ml | 16.4 | 59.4 | Same |
| Chloroquine 50.0 mg/ml | Not tested | > 240 | Different |
| Cisplatin 1 mg/ml | > 240 | > 240 | Same |
| Cyclophosphamide 20 mg/ml | > 240 | > 240 | Same |
| Cyclosporin A 100.0 mg/ml | Not tested | > 240 | Different |
| Cytarabine 100.0 mg/ml | Not tested | > 240 | Different |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 | > 240 | Same |
| Daunorubicin 5.0 mg/ml | Not tested | > 240 | Different |
| Docetaxel 10.0 mg/ml | > 240 | > 240 | Same |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 | > 240 | Same |
| Epirubicin 2.0 mg/ml | > 240 | > 240 | Same |
| Etoposide (Toposar), 20.0 mg/ml | > 240 | > 240 | Same |
| Fludarabine 25.0 mg/ml | Not tested | > 240 | Different |
| Fluorouracil, 50.0 mg/ml | > 240 | > 240 | Same |
| Gemcitabine 38.0 mg/ml | > 240 | > 240 | Same |
| Idaribicin 1.0 mg/ml | Not tested | > 240 | Different |
| Ifosfamide 50.0 mg/ml | > 240 | > 240 | Same |
| Irinotecan 20.0 mg/ml | > 240 | > 240 | Same |
| Mechlorethamine HCl 1.0 mg/ml | Not tested | > 240 | Different |
| Melphalan 5 mg/ml | Not tested | > 240 | Different |
| Methotrexate 25 mg/ml | > 240 | > 240 | Same |
| Mitomycin C 0.5 mg/ml | > 240 | > 240 | Same |
| Mitoxantrone 2.0 mg/ml | > 240 | > 240 | Same |
| Oxaliplatin 2.0 mg/ml | > 240 | > 240 | Same |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 | > 240 | Same |
| Paraplatin 10 mg/ml | Not tested | > 240 | Different |
| Retrovir 10 mg/ml | Not tested | > 240 | Different |
| Rituximab 10 mg/ml | Not tested | > 240 | Different |
| Thiotepa, 10.0 mg/ml | 98.6 | 118.5 | Different |
| Topotecan HCl 1 mg/ml | Not tested | > 240 | Different |
| Trisonex 1 mg/ml | Not tested | > 240 | Different |
| Velcade (Bortezomib) 1 mg/ml | Not tested | > 240 | Different |
| Vincristine 1.0 mg/ml | > 240 | > 240 | Same |
Table1-Comparison of Subject and Predicate Devices
7
8
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs was conducted in accordance with the following standards:
9
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
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010 | |||
| Tests For Irritation And | |||
| Skin Sensitization | To determine if device | ||
| is a skin irritant | The device must be a | ||
| non-irritant | Pass | ||
| ISO 10993-10:2010 | |||
| Tests For Irritation And | |||
| Skin Sensitization | To determine if device | ||
| is a skin sensitizer | The device must be a | ||
| non- sensitizer | Pass | ||
| ISO 10993-5:2009 | |||
| Tests For In Vitro | |||
| Cytotoxicity | To determine if the | ||
| device is potential | |||
| toxicity to L-929 | |||
| cells. | The device must be a | ||
| non toxicity. | Pass | ||
| Test Method | Purpose | Acceptance Criteria | Results(2 mg/glove) |
| ASTM D6124-06 | |||
| (Reapproved 2017) | |||
| Standard Test Method | |||
| for Residual Powder on | |||
| Medical Gloves | To determine residual | ||
| powder | ≤ 2 mg/glove | S:0.02 | |
| M:0.12 | |||
| L:0.16 | |||
| XL:0.14 | |||
| Pass | |||
| ASTMD5151-19 | |||
| Standard Test Method | |||
| for Detection of Holes | |||
| in Medical Gloves | To determine water | ||
| tightness | Meet the requirements | ||
| of ASTM D5151 AQL | |||
| 2.5 | S:0/125 leaks | ||
| M: 0/125 leaks | |||
| L: 0/125 leaks | |||
| XL: 0/125 leaks | |||
| Pass | |||
| ASTM D5250-19 | |||
| Standard Specification | |||
| for Poly (vinyl chloride) | |||
| Gloves for Medical | |||
| Application | To determine physical | ||
| dimensions | Length(mm):S:≥220. | Length(mm):>230 | |
| M/L/XL: ≥230 | Width(mm): | ||
| Width(mm): | S: 88 | ||
| S: 80±10; | M: 98-99 | ||
| M: 95±10; | L: 110-112 | ||
| L: 110±10; | XL: 115-117 | ||
| XL: 120±10; | Pass | ||
| Thickness (mm): | Finger: 0.101-0.128 | ||
| Finger: ≥0.05 | Palm: 0.067-0.78 | ||
| Palm: ≥0.05 | Pass | ||
| ASTM D412-06a-2013 | |||
| Standard Test Methods | |||
| for Vulcanized Rubber | |||
| and Thermoplastic | |||
| Elastomers-Tension | To determine physical | ||
| properties | Before Aging: | ||
| Tensile | |||
| Strength≥14MPa | |||
| Ultimate | |||
| Elongation≥500% | Before Aging: | ||
| Tensile Strength: | |||
| 25.4 ~36.3 MPa | |||
| Ultimate Elongation: | |||
| 508%~563% | |||
| After Aging: | |||
| Tensile | |||
| Strength≥14MPa | |||
| Ultimate | |||
| Elongation≥400% | After Aging: | ||
| Tensile Strength: | |||
| 25.8~35.6 MPa | |||
| Ultimate Elongation: | |||
| 483%~525% | |||
| Pass | |||
Table 2 Biocompatibility Testing
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
- -ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D 6978-05 (Reapproved 2019). Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Table 3 Non-Clinical Testing
10
9.0 _Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Powder Free Examination Gloves,Tested For Use With
11
Chemotherapy Drugs is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190736.