(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical resistance of examination gloves, with no mention of AI or ML technologies.
No.
The device (patient examination gloves) is intended to prevent contamination between patient and examiner, and for protection against chemotherapy drugs, not to treat or cure a disease or condition.
No
The device is a medical glove intended to prevent contamination between patient and examiner and has undergone performance testing related to physical properties and chemical permeation, not diagnostic capabilities.
No
The device is a physical medical device (gloves) and the description focuses on material properties, physical dimensions, and chemical resistance, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or fingers. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on physical characteristics (disposable, single use, powder-free, ambidextrous, beaded cuff, color, material, size) and performance related to physical properties and chemical resistance.
- Performance Studies: The performance studies are focused on biocompatibility, physical properties (dimensions, watertightness, tensile strength, elongation), and chemotherapy drug permeation. These are all related to the device's function as a barrier and protective item, not to diagnosing a condition or analyzing a sample in vitro.
- Key Metrics: The listed "Key Metrics" are "Not Applicable," and the description clarifies that performance metrics are related to physical properties and chemical permeation, not diagnostic accuracy.
- No mention of analyzing samples: There is no indication that this device is used to collect, prepare, or analyze samples from the human body in vitro to provide information for diagnosis, monitoring, or treatment.
In summary, this device is a medical glove intended for protection and barrier function, not for performing diagnostic tests on samples outside the body.
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 |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 10.9 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil (Adrucil) | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| Thio TEPA | 10.0 mg/ml(10,000 ppm) | 15.2 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 10.9 Minutes Thio-Tepa 10.0 mg/ml 15.2 Minutes
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
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 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. The subject device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands or fingers (worn on the examiner's hand or fingers)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purpose)
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)
Non-Clinical Testing:
Biocompatibility Testing:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.
- ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.
Performance Testing (Bench): - Evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
- Permeation testing conducted according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, for minimum breakthrough times for chemotherapy drugs.
- Additional tests: ASTM D6124-06 (Reapproved 2017) for Residual Powder on Medical Gloves, ASTM D5151-19 for Detection of Holes in Medical Gloves.
Summary of non-clinical performance testing results: - ASTM D6319 (Physical Dimensions Test):
- Length: > 240/Pass
- Width: S: 86-88 /Pass; M: 98-99/ Pass; L: 109-111/ Pass; XL:115-117/ Pass
- Thickness: Finger: 0.11-0.12/Pass; Palm: 0.09-0.10/Pass
- ASTM D5151 (Watertightness Test for Detection of Holes): 0/125/Pass (Meets AQL 2.5)
- ASTM D6124 (Powder Content): 0.15mg/Pass (Meets =14MPa); Ultimate Elongation: 546-778/Pass (>=500%)
- After Aging: Tensile Strength: 14.4-16.1/Pass (>=14MPa); Ultimate Elongation: 579-699/Pass (>=400%)
- ISO 10993-11 (Toxicity): Under conditions of the study, did not show acute systemic toxicity in vivo / Pass
- ISO 10993-10 (Irritation): Under the conditions of the study, not an irritant/ Pass
- ISO 10993-10 (Sensitization): Under conditions of the study, not a sensitizer / Pass
Clinical Testing:
Clinical testing is not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for physical and chemical properties. Breakthrough Detection Time for chemotherapy drugs:
- Carmustine (BCNU): 10.9 Minutes
- Cisplatin: > 240 Minutes
- Cyclophosphamide (Cytoxan): > 240 Minutes
- Dacarbazine (DTIC): > 240 Minutes
- Doxorubicin HCl: > 240 Minutes
- Etoposide: > 240 Minutes
- Fluorouracil: > 240 Minutes
- Paclitaxel: > 240 Minutes
- Thio Tepa: 15.2 Minutes
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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 7, 2021
Guangdong Gymda Medical Technology Co.,ltd Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai. 200120 China
Re: K212506
Trade/Device Name: Medical Examination Gloves (Tested for Use with Chemotherapy) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: July 30, 2021 Received: August 9, 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.
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 and Part 809); 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) K212506
Device Name
Medical Examination Gloves (Tested for Use with Chemotherapy)
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 |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 10.9 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil (Adrucil) | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| Thio TEPA | 10.0 mg/ml(10,000 ppm) | 15.2 Minutes |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 10.9 Minutes Thio-Tepa 10.0 mg/ml 15.2 Minutes
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
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.
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."
3
510(k) Summary-K212506
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD Name: Address: No.13, Quan'an Third Road, Phase 2 of High-tech Zone, Nanxiong City, Shaoguan City, Guangdong Province, 512400, China Contact: Olivia Chen Date of Preparation: Jul 30, 2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Medical Examination Gloves (Tested for Use with Chemotherapy) Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove S, M, L, XL Model(s):
3.0 Classification
Production code: LZA.LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Ever Growth (Vietnam) Co., Ltd. Manufacturer:
Device: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color
510(k) number: K190860
4
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 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. The subject device is non-sterile.
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 |
|-------------------------------|------------------------|-------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 10.9 |
| 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 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 15.2 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 10.9 Minutes; Thio Tepa 10.0 mg/ml 15.2 Minutes.
Warning: Please do not use with Carmustine (BCNU) and Thiotepa.
7.0 Technological Characteristic Comparison Table
Table1-General Comparison
| Item | Subject Device
(K212506) | Predicate Device
(K190860) | Remark |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Product Code | LZA,LZC | LZA,LZC | 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 |
| 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 |
| Dimensions(mm) | Length:
S:≥220;
M/L/XL: ≥230;
Width:
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 | Length:
XS/S/M/L/XL: ≥230;
Width:
XS:70±10;
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 | Similar
Analysis
1 |
| Thickness(mm) | Finger: ≥0.05;
Palm: ≥0.05 | Finger: ≥0.05;
Palm: ≥0.05 | Same |
5
6
| | | | | | | Analysis
2 |
|------------------------|-----------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Physical
Properties | | Tensile
Strength | 14MPa, min | Tensile
Strength | 14MPa, min | Same |
| | Before
Aging | Ultimate
Elongation | 500% min | Ultimate
Elongation | 500% min | Same |
| | After
Aging | Tensile
Strength | 14MPa, min | Tensile
Strength | 14MPa, min | Same |
| | | Ultimate
Elongation | 400%min | Ultimate
Elongation | 400%min | 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 | | | 0.15 mg per glove, Meet the requirements of
ASTM D6124 | | Meet the requirements of
ASTM D6124 | Similar
Analysis
3 |
| Biocompatibility | | | ISO 10993-10;
Under the conditions of the study, not an irritant
or a sensitizer
ISO 10993-5
Under conditions of the
study, device extract is
cytotoxic
ISO 10993-11;
Under the
condition of acute
systemic toxicity test,
the test article did not
show acute systemic
toxicity in vivo. | | ISO 10993-10;
Under the conditions of the study, not an irritant
or a sensitizer
ISO 10993-5
Under conditions of the
study, device extract is
not cytotoxic
N.A. | Same
/
/ |
| | | | Carmustine (BCNU) 3.3
mg/ml: 10.9 Minutes | | Carmustine (BCNU) 3.3
mg/ml:
White:11.8 Minutes;
Orange:31.6Minutes | Similar
Analysis 4 |
| | | | Cisplatin 1.0 mg/ml: > 240
Minutes | | Cisplatin 1.0 mg/ml: > 240
Minutes | Same |
7
| 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 |
| | Paclitaxel 6.0 mg/ml: >240
Minutes | Paclitaxel (Taxol) 6.0
mg/ml:
240 Minutes | Same |
| | Thio Tepa 10.0 mg/ml: 15.2
Minutes | Thio-Tepa 10.0 mg/ml:
White:16.9 Minutes;
Orange: 72.5 Minutes | Similar
Analysis 5 |
Analysis 1:
The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
Analysis 2:
The color of the subject device is different with that of the predicate. The subject device was evaluated according to ISO 10993-1 standards, and there were no risks identified.
Analysis 3:
Powder Content of subject device is similar with that of the predicate, because the predicate did not publish the exact results of the powder content. But they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
Analysis 4:
And Breakthrough detection times of Carmustine (BCNU) and Thio Tepa of subject device are different with those of the predicate. The Chemotherapy Labeling Claims has clearly defined on the labeling. So it does not raise any new safety or performance questions.
8
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Medical Examination Gloves (Tested for Use with Chemotherapy) 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 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
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 2 - Summary of non-clinical performance testing
9
| Test
| Method | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| ASTM | ||||
| D6319 | Physical | |||
| Dimensions | ||||
| Test | Length(mm): | |||
| S:≥220; | ||||
| M/L/XL:≥230; | Length: |
240/Pass; | |
| | | Width(mm):
S: 80±10; | Width:
S: 86-88 /Pass | |
| | | M: 95±10; | M: 98-99/ Pass | |
| | | L: 110±10; | L: 109-111/ Pass | |
| | | XL: 120±10 | XL:115-117/ Pass | |
| | | Thickness (mm):
Finger: ≥0.05
Palm: ≥0.05 | Finger: 0.11-0.12/Pass | |
| | | | Palm: 0.09-0.10/Pass | |
| | | | | |
| ASTM
D5151 | Watertightness
Test for
Detection of
Holes | Meet the requirements of ASTM D5151
AQL 2.5 | 0/125/Pass | |
| ASTM
D6124 | Powder
Content | Meet the requirements of ASTM D6124