(114 days)
Not Found
No
The document describes a standard medical examination glove and its performance characteristics, with no mention of AI or ML technology.
No
The device is a patient examination glove, which is a barrier to prevent contamination, not a device intended to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove, described as a barrier to prevent contamination between patient and examiner. Its purpose is to protect, not to diagnose medical conditions or analyze bodily functions.
No
The device is a physical medical device (gloves) and does not involve any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a patient examination glove. Its primary function is to act as a physical barrier to prevent contamination between a patient and an examiner. It is a protective device worn on the hands.
- Lack of Diagnostic Testing: The device does not perform any tests on biological samples to provide diagnostic information. Its testing for chemotherapy drug resistance relates to its barrier properties and safety for the user, not to diagnosing a patient's condition.
The information provided clearly indicates the device's purpose is for personal protection and contamination prevention during medical examinations, not for performing diagnostic tests on patient samples.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.2 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 |
| Doxorubicin 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 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 Minutes |
| Miromycin C | 0.5 mg/ml(500 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 45.8 Minutes |
| Vincristine Sulface | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 15.2 Minutes Thio-Tepa 10.0 mg/ml 45.8 Minutes
Warning: Please do not use with Carmustine
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 to prevent contamination between patient and examiner. The qloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's hands / 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 Evaluation:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation And Skin Sensitization.
- Results: Under the conditions of the study, not an irritant and not a sensitizer.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests For In Vitro Cytotoxicity.
- Results: Under conditions of the study, device extract is not cytotoxic.
Performance Testing (Bench):
- Physical performance qualities were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
- Permeation testing was conducted per ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, to determine minimum breakthrough times for various chemotherapy drugs.
Summary of Non-Clinical Testing Results (Table 5 Performance Testing Summary):
- ASTM D6319 - Physical Dimensions Test:
- Length: XS/S:≥220; M/L/XL: ≥230. Results: 230 for all sizes. Pass.
- Width: XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10. Results: XS: 77-79; S: 82-86; M: 95-97; L: 104-106; XL: 115-117. Pass.
- Thickness (mm): Finger: ≥0.05; Palm: ≥0.05. Results: XS: Finger 0.10-0.12, Palm 0.06-0.10; S: Finger 0.09-0.12, Palm 0.07-0.09; M: Finger 0.08-0.12, Palm 0.06-0.09; L: Finger 0.10-0.13, Palm 0.06-0.09; XL: Finger 0.11-0.12, Palm 0.06-0.08. Pass.
- ASTM D5151 - Watertightness Test for Detection of Holes:
- Acceptance Criteria: AQL 2.5. Results: XS:0/125 leaks; S:1/125 leaks; M:0/125 leaks; L:2/125 leaks; XL:2/125 leaks. Pass.
- ASTM D6124 - Powder Content:
- Acceptance Criteria: 240 Minutes.
- Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes.
- Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes.
- Doxorubicin HCl 2.0 mg/ml: > 240 Minutes.
- Etoposide 20.0 mg/ml: > 240 Minutes.
- Fluorouracil 50.0 mg/ml: > 240 Minutes.
- Methotrexate 25 mg/ml: > 240 Minutes.
- Mitomycin C 0.5 mg/ml: > 240 Minutes.
- Paclitaxel 6.0 mg/ml: > 240 Minutes.
- Thio Tepa 10.0 mg/ml: 45.8 Minutes.
- Vincristine Sulfate 1.0 mg/ml: > 240 Minutes.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
December 30, 2021
Siyang Threeguard Medical Supplies Co.,Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K212834
Trade/Device Name: Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: November 22, 2021 Received: December 01, 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 mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212834
Device Name
Disposable Nitrile Medical Examination Glove(Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.2 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 |
| Doxorubicin 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 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | > 240 Minutes |
| Miromycin C | 0.5 mg/ml(500 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| ThioTepa | 10.0 mg/ml(10,000 ppm) | 45.8 Minutes |
| Vincristine Sulface | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 15.2 Minutes Thio-Tepa 10.0 mg/ml 45.8 Minutes
Warning: Please do not use with Carmustine
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
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4
510(k) Summary (K212834)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Siyang Threeguard Medical Supplies Co., Ltd. |
|---|---|
| Address: | East of Nanhai Road and South of Guilin Road,Economic |
| development zone,Siyang County, Suqian city, Jiangsu, | |
| 223799, China. | |
| Phone Number: | +86-13485097856 |
| Contact: | Guo Hua |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai |
| 200120,China | |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
| Date of Preparation: | December 20,2021 |
2.0 Device Information
| Trade name: | Disposable Nitrile Medical Examination Glove(Tested for Use with Chemotherapy Drugs) |
|---|---|
| Common name: | Patient Examination Gloves |
| Classification name: | Non-powdered patient examination glove |
| Model(s): | XS,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
5
Manufacturer: Medline Industries, Inc. Device: Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) 510(k) number: K201390
5.0 Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The qloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.
6.0 Indication for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection
Time in Minutes |
|-------------------------------|------------------------|-------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.2 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCl | 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 |
| Methotrexate | 25 mg/ml(25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 45.8 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | > 240 |
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 15.2 Minutes;
Thio Tepa 10.0 mg/ml 45.8 Minutes.
6
Caution: Testing showed an average breakthrough time of 45.8 minutes with Thio-Tepa WARNING: Do not use with Carmustine
7.0 Comparison of Technological Characteristics With The Predicate Device
| Item | Subject Device
(K212834) | Predicate Device
(K201390) | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | 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. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | 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. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | Same |
| Powdered or
Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | 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. | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
7
| Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|
| Predicate | |||||||
| Device(K201390) | Length, mm | NA | 240 | 240 | 240 | 240 | min |
| Width, mm | NA | 85 | 95 | 105 | 115 | ±10 | |
| Thickness, mm: | |||||||
| Finger | 0.16 | min | |||||
| Palm | 0.14 | min | |||||
| Subject | |||||||
| Device | |||||||
| (K212834) | Designation | XS | S | M | L | XL | |
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Different |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19.
Table3 Performance Comparison
| Item | | Subject device
(K212834) | Predicate device
(K201390) | Remark | |
|------------------------|-----------------|---------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------|-----------|
| Colorant | | Blue | Light Blue | Different | |
| Physical
Properties | Before
Aging | Tensile Strength | 14Mpa, min | 17Mpa, min | Different |
| | | Ultimate Elongation | 500% min | 500% min | Same |
| | After
Aging | Tensile Strength | 14Mpa, min | 14Mpa, min | Same |
| | | Ultimate Elongation | 400%min | 400%min | Same |
| | | Comply with ASTM D6319 | | Comply with ASTM D6319 | Same |
| Freedom from Holes | | Be free from holes when tested
in accordance with
ASTMD5151 AQL=2.5 | | Be free from holes when tested
in accordance with
ASTMD5151 AQL=2.5 | Same |
| Powder Content | | Meet the requirements of
ASTM D6124 240
Minutes | | Cisplatin 1.0 mg/ml: ≥240 | Same |
8
| Minutes | |||
|---|---|---|---|
| Chemotherapy Drugs | |||
| Tested with Minimum | |||
| Breakthrough | |||
| Detection Time as | |||
| Tested per ASTM D | |||
| 6978 | Cyclophosphamide (Cytoxan) | ||
| 20.0 mg/ml: > 240 Minutes | Cyclophosphamide (Cytoxan) | ||
| 20.0 mg/ml: ≥240 Minutes | Same | ||
| Dacarbazine (DTIC) 10.0 | |||
| mg/ml: > 240 Minutes | Dacarbazine (DTIC) | ||
| 10.0 mg/ml: | |||
| ≥240 Minutes | Same | ||
| Doxorubicin HCl 2.0 mg/ml: > | |||
| 240 Minutes | Doxorubicin | ||
| Hydrochloride 2.0 | |||
| mg/ml: ≥240 Minutes | Same | ||
| Etoposide 20.0 mg/ml: > 240 | |||
| Minutes | Etoposide (Toposar) | ||
| 20.0 | |||
| mg/ml: ≥240 Minutes | Same | ||
| Fluorouracil 50.0 mg/ml: >240 | |||
| Minutes | Fluorouracil 50.0 | ||
| mg/ml: ≥240 | |||
| Minutes | Same | ||
| Methotrexate 25 mg/ml: >240 | |||
| Minutes | Methotrexate 25 | ||
| mg/ml: ≥240 | |||
| Minutes | Same | ||
| Mitomycin C 0.5 mg/ml: > | |||
| 240 Minutes | Mitomycin C 0.5 | ||
| mg/ml: ≥ 240 | |||
| Minutes | Same | ||
| Paclitaxel 6.0 mg/ml: > 240 | |||
| Minutes | Paclitaxel (Taxol) 6.0 | ||
| mg/ml: | |||
| ≥240 Minutes | Same | ||
| Thio Tepa 10.0 mg/ml: 45.8 | |||
| Minutes | Thio-Tepa 10.0 mg/ml: | ||
| 43.7 | |||
| Minutes | Different | ||
| Vincristine Sulfate 1.0 mg/ml: |
240 Minutes | Vincristine Sulfate
(Oncovin) 1.0
mg/ml: ≥240 Minutes | Same |
Table4 Safety Comparison
| Item | Subject device
(K212834) | Predicate device
(K201390) | Remark | |
|------------------|---------------------------------------------------------------|-------------------------------------------------|----------------------------|------|
| Material | Nitrile
Color Additive
Liquid Chlorine | Nitrile
Color Additive
Liquid
Chlorine | Same | |
| Biocompatibility | Irritation (ISO 10993-
10:2010 Biological
Evaluation of | Under the
conditions of
the study, not | Comply with
ISO10993-10 | Same |
9
| Medical Devices –
Part 10: Tests For
Irritation And Skin
| Sensitization) | an irritant | ||
|---|---|---|---|
| Sensitization (ISO | |||
| 10993-10:2010 | |||
| Biological Evaluation | |||
| of Medical Devices – | |||
| Part 10: Tests For | |||
| Irritation And Skin | |||
| Sensitization) | Under | ||
| conditions of | |||
| the study, not a | |||
| sensitizer. | |||
| Cytotoxicity (ISO | |||
| 10993-5:2009 | |||
| Biological Evaluation | |||
| of Medical Devices – | |||
| Part 5: Tests For In | |||
| Vitro Cytotoxicity) | Under | ||
| conditions of | |||
| the study, device extract | |||
| is not cytotoxic | Under | ||
| conditions of | |||
| the study, device extract | |||
| is cytotoxic | Different | ||
| Acute Systemic | |||
| Toxicity(ISO 10993- | |||
| 11:2017,Biological | |||
| evaluation of medical | |||
| devices - Part 11: | |||
| Tests for systemic | |||
| toxicity.) | N/A | Under | |
| conditions of | |||
| the study, device extract | |||
| is non-toxic | Different |
8.0 Summary of Non-Clinical Testing
The biocompatibility evaluation for Disposable Nitrile Medical Examination Glove(Tested for Use with Chemotherapy Drugs) was conducted in accordance with the following standards:
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
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
10
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.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical | ||
| Dimensions | |||
| Test | Length(mm): | ||
| XS/S:≥220; | |||
| M/L/XL: ≥230; | Length: >230 | ||
| Width(mm): | |||
| XS: 70±10; | |||
| S: 80±10; | |||
| M: 95±10; | |||
| L: 110±10; | |||
| XL: 120±10 | Width: | ||
| XS: 77-79; | |||
| S: 82-86 | |||
| M: 95-97 | |||
| L: 104-106 | |||
| XL: 115-117 | |||
| Pass | |||
| Thickness (mm) : | |||
| Finger: ≥0.05 | |||
| Palm: ≥0.05 | XS: | ||
| Finger: 0.10-0.12 | |||
| Palm: 0.06-0.10 | |||
| S: | |||
| Finger: 0.09-0.12 | |||
| Palm: 0.07-0.09 | |||
| M: | |||
| Finger: 0.08-0.12 | |||
| Palm: 0.06-0.09 | |||
| L: | |||
| Finger: 0.10-0.13 | |||
| Palm: 0.06-0.09 |
Table 5 Performance Testing Summary
11
| XL: | |||||
|---|---|---|---|---|---|
| Finger: 0.11-0.12 | |||||
| Palm: 0.06-0.08 | |||||
| Pass | |||||
| ASTM D5151 | Watertightness | ||||
| Test for | |||||
| Detection of | |||||
| Holes | Meet the requirements of | ||||
| ASTM D5151 AQL 2.5 | XS:0/125 leaks | ||||
| S:1/125 leaks | |||||
| M:0/125 leaks | |||||
| L:2/125 leaks | |||||
| XL:2/125 leaks | |||||
| Pass | |||||
| ASTM D6124 | Powder Content | Meet the requirements of | |||
| ASTM D6124 240 Minutes | |||||
| Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes | |||||
| Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes | |||||
| Doxorubicin HCl 2.0 mg/ml: > 240 Minutes | |||||
| Etoposide 20.0 mg/ml: > 240 Minutes | |||||
| Fluorouracil 50.0 mg/ml: > 240 Minutes | |||||
| Methotrexate 25 mg/ml: > 240 Minutes | |||||
| Mitomycin C 0.5 mg/ml: > 240 Minutes | |||||
| Paclitaxel 6.0 mg/ml: > 240 Minutes | |||||
| Thio Tepa 10.0 mg/ml: 45.8 Minutes | |||||
| Vincristine Sulfate 1.0 mg/ml: > 240 Minutes | |||||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. | ||
| Pass | |||||
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. | ||
| Pass | |||||
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. | ||
| Pass |
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, Disposable Nitrile Medical Examination Glove(Tested for Use with
13
Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K201390.