(134 days)
Not Found
No
The device is a physical glove and the description focuses on material properties and performance testing, with no mention of AI or ML.
No.
The device is a glove for preventing contamination, not for treating a disease or condition.
No
The device is described as disposable examination gloves, which are used to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical product (nitrile gloves) and the description focuses on material properties, physical performance, and testing related to those properties, 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 clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
- Device Description: The description reinforces this, detailing the physical characteristics of the gloves and their purpose in preventing contamination.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Testing: The testing described focuses on the physical properties of the gloves, their ability to prevent permeation by chemotherapy drugs, and biocompatibility – all relevant to a protective barrier device, not an IVD.
Therefore, the Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are classified as a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue, powder free, nitrile gloves. The gloves are offered in sizes small, medium, large, extra large, and packaged in a color paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05(2019).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Physical performance qualities of the proposed device were evaluated per ASTM D6319- 19, 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(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.
ASTM D 6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
Physical Dimensions:
Length (mm): >=220 (S), >=230 (M, L, XL) - Pass
Width (mm) +-10: 80+-10 (S), 95+-10 (M), 110+-10 (L), 120+-10 (XL) - Pass
Thickness Finger/Palm: >=0.05 mm - Pass
Physical properties:
Before Aging: Tensile >=14Mpa; Elongation >=500% - Pass
After Aging: Tensile >=14Mpa; Elongation >=400% - Pass
ASTM D 5151-19 Standard Test Method for Detection of Holes in Medical Gloves
Watertightness Test for detection of holes: Batch size=35000, sample 125
§ 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). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
January 11, 2022
Xingyu Medical Tech Co., Ltd. % Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, Shanghai 200122 China
Re: K212735
Trade/Device Name: Nitrile disposable 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: December 16, 2021 Received: December 16, 2021
Dear Eva Li:
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) K212735
Device Name
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
Indications for Use (Describe)
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough time |
|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml (3,300ppm) | 47.9(68.2,47.9,69.3) |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml (20,000ppm) | >240 min |
| Doxorubicin HCI | 2.0 mg/ml (2,000ppm) | >240 min |
| Etoposide | 20.0 mg/ml (20,000ppm) | >240 min |
| Fluorouracil | 50.0 mg/ml (50,000ppm) | >240 min |
| Paclitaxel | 6.0 mg/ml (6,000ppm) | >240 min |
| ThioTepa | 10.0 mg/ml (10,000ppm) | >240 min |
| Bleomycin Sulfate(Blenoxane) | 15mg/ml (15,000ppm) | >240 min |
| Carboplatin | 10 mg/ml (10,000ppm) | >240 min |
| Cisplatin | 1.0 mg/ml (1,000ppm) | >240 min |
| Cytarabine | 100mg/ml(100,000ppm) | >240 min |
| Dacarbazine | 10.0mg/ml (10,000ppm) | >240 min |
| Idarubicin HCL | 1mg/ml (1,000ppm) | >240 min |
| Ifosfamide | 50mg/ml (50,000ppm) | >240 min |
| Mechlorethamine HCL | 1mg/ml (1,000ppm) | >240 min |
| MESNA | 100mg/ml (100,000ppm) | >240 min |
| Methotrexate | 25mg/ml (25,000ppm) | >240 min |
| Mitomycin C | 0.5 mg/ml (500ppm) | >240 min |
| Mitoxantrone | 2mg/ml(2,000ppm) | >240 min |
| Trisenox | 1 mg/ml(1,000ppm) | >240 min |
| Vincristine Sulfate | 1 mg/ml (1,000ppm) | >240 min |
| 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
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4
XINGYU MEDICAL TECH CO.,LTD.
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
510K Summary
The assigned 510(k) number is: K212735
Premarket Notification [510(k)] Summary
1. Submitter / 510(k) Sponsor:
Submitter's name : XINGYU MEDICAL TECH CO.,LTD. Submitter's Address: NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE, CHINA Phone number: 0086-18263618867 Contact person: Cathrine Luan Email: cathrine@xingyugloves.com
Submission Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
Date of Preparation: 2021-12-14
2. Proposed Device
Device Name / Classification Trade Name: Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) Common Name: Patient examination glove Classification Name: Medical Gloves with Chemotherapy Labeling Claims – Test For Use with Chemotherapy Drugs Product Code: LZA. LZC Classification Panel: General Hospital Regulatory Class: Class I Regulation Number: 21 CFR 880.6250
3. Predicate Device
Device Name: Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with
5
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
Chemotherapy Drugs) Company Name: Medline Industries, Inc. 510(K) Number: K200960
4. Device Description
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue, powder free, nitrile gloves. The gloves are offered in sizes small, medium, large, extra large, and packaged in a color paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05(2019).
5. Indications for Use
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough time |
|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml (3,300ppm) | 47.9 |
| (68.2,47.9,69.3) | ||
| Cyclophosphamide | ||
| (Cytoxan) | 20.0mg/ml (20,000ppm) | > 240 min |
| Doxorubicin HCI | 2.0 mg/ml (2,000ppm) | > 240 min |
| Etoposide | 20.0 mg/ml (20,000ppm) | > 240 min |
| Fluorouracil | 50.0 mg/ml (50,000ppm) | > 240 min |
| Paclitaxel | 6.0 mg/ml (6,000ppm) | > 240 min |
| ThioTepa | 10.0 mg/ml (10,000ppm) | > 240 min |
| Bleomycin | ||
| Sulfate (Blenoxane) | 15mg/ml (15,000ppm) | > 240 min |
| Carboplatin | 10 mg/ml (10,000ppm) | > 240 min |
| Cisplatin | 1.0 mg/ml (1,000ppm) | > 240 min |
| Cytarabine | 100mg/ml(100,000ppm) | > 240 min |
| Dacarbazine | 10.0mg/ml (10,000ppm) | > 240 min |
| Idarubicin HCL | 1mg/ml (1,000ppm) | > 240 min |
| Ifosfamide | 50mg/ml (50,000ppm) | > 240 min |
| Mechlorethamine HCL | 1mg/ml (1,000ppm) | > 240 min |
| MESNA | 100mg/ml (100,000ppm) | > 240 min |
| Methotrexate | 25mg/ml (25,000ppm) | > 240 min |
| Mitomycin C | 0.5 mg/ml (500ppm) | > 240 min |
| Mitoxantrone | 2mg/ml(2,000ppm) | > 240 min |
6
XINGYU MEDICAL TECH CO.,LTD.
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
K212735(Page 3 / 7)
CHINA
| Trisenox | 1 mg/ml(1,000ppm) | > 240 min |
|---|---|---|
| Vincristine Sulfate | 1 mg/ml (1,000ppm) | > 240 min |
Do Not Use with Carmustine (BCNU).
6. Summary of Technological Characteristics
Table2: Comparison of Proposed and Predicate Devices
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Nitrile disposable examination
gloves (Tested for use with
Chemotherapy Drugs) | Medline Nitrile Powder Free
Dark Blue Examination Gloves
(Tested for use with
Chemotherapy Drugs) | |
| 510(k)
Reference | K212735 | K200960 | |
| Product Owner | XINGYU MEDICAL TECH CO.,LTD. | Medline | |
| Product Code | LZA, LZC | LZA, LZC | 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. | 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. | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Design
Configurations | Blue | Dark Blue | Similar |
| Materials | Nitrile | Nitrile | Same |
| Prescription vs.
OTC | OTC | OTC | Same |
| Contact
Durations | Limited ≤ 24 hours | Limited ≤ 24 hours | Same |
| Sterile vs. Non-
Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs.
Non-Disposable | Disposable | Disposable | Same |
| Single Use vs.
Reusable | Single Use | Single Use | Same |
| Dimensions-
Width | Complies with: ASTM D6319-19
70mm min | Complies with: ASTM D6319-10
70mm min | Same |
| Dimensions- | Complies with: ASTM D6319-19 | Complies with: ASTM D6319-10 | Same |
7
K212735(Page 4 / 7)
XINGYU MEDICAL TECH CO.,LTD.
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
| Thickness | Palm - 0.05mm min. Finger –
0.05mm min | | Palm - 0.05mm min. Finger –
0.05mm min | | | | |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------------------|----------------------|---------|
| Physical
Properties | Complies with: ASTM D6319-19
minimum:
Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation: Before Aging 500%, min.
After Aging 400%, min. | | Complies with: ASTM D6319-10
minimum:
Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation: Before Aging 500%, min.
After Aging 400%, min. | | Same | | |
| Freedom from
holes | Complies with: ASTM D6319-19
and ASTM D5151-19 G-1,
AQL 1.5 | | Complies with: ASTM D6319-10
and ASTM D5151-06 G-1,
AQL 1.5 | | Same | | |
| Powder or
Powder Free | Powder Free | | Powder Free | | Same | | |
| Residual
Powder | Complies with ASTM D6319-19 | | Complies with ASTM D6319-10 | | Same | | |
| Biocompatibility | Complies with AAMI/ANSI/ISO
10993-10: Not a skin irritant Not
a skin sensitizer AAMI/ANSI/ ISO
10993-11: Non-Toxic | | Complies with AAMI/ANSI/ISO
10993-10: Not a skin irritant
Not a skin sensitizer
AAMI/ANSI/ ISO 10993-11: Non-Toxic | | Same | | |
| Chemotherapy
Drugs Tested
with Minimum
Breakthrough
Detection Time
as tested per
ASTM D6978 | Chemotherapy Drug | Concentration | Breakthrough
time | Chemotherapy
Drug | Concentration | Breakthrough
time | Simliar |
| | Carmustine (BCNU) | 3.3mg/ml (3,300ppm) | 47.9
(68.2,47.9,69.3) | Carmustine
(BCNU) | 3.3 mg/ml
(3,300 ppm) | 12.4 minutes | |
| | Cyclophosphamide
(Cytoxan) | 20.0mg/ml (20,000ppm) | > 240 min | Cisplatin | 1.0 mg/ml
(1,000 ppm) | >240 minutes | |
| | Doxorubicin HCl | 2.0 mg/ml (2,000ppm) | > 240 min | Cyclophosphamide
(Cytoxan) | 20.0 mg/ml
(20,000 ppm) | >240 minutes | |
| | Etoposide | 20.0 mg/ml
(20,000ppm) | > 240 min | Dacarbazine
(DTIC) | 10.0 mg/ml
(10,000 ppm) | >240 minutes | |
| | Fluorouracil | 50.0 mg/ml
(50,000ppm) | > 240 min | Doxorubicin
Hydrochloride | 2.0 mg/ml
(2,000 ppm) | >240 minutes | |
| | Paclitaxel | 6.0 mg/ml (6,000ppm) | > 240 min | Etoposide
(Toposar) | 20.0 mg/ml
(20,000 ppm) | >240 minutes | |
| | Thio Tepa | 10.0 mg/ml
(10,000ppm) | > 240 min | Fluorouracil | 50.0 mg/ml
(50,000 ppm) | >240 minutes | |
| | Bleomycin
Sulfate(Blenoxane) | 15mg/ml (15,000ppm) | > 240 min | Methotrexate | 25 mg/ml
(25,000 ppm) | >240 minutes | |
| | Carboplatin | 10 mg/ml (10,000ppm) | > 240 min | Mitomycin C | 0.5 mg/ml (500
ppm) | >240 minutes | |
| | Cisplatin | 1.0 mg/ml
(1,000ppm) | > 240 min | Paclitaxel (Taxol) | 6.0 mg/ml
(6,000 ppm) | >240 minutes | |
| | Cytarabine | 100mg/ml(100,000ppm) | > 240 min | Thio Tepa | 10.0 mg/ml
(10,000 ppm) | 27.4 minutes | |
| | Dacarbazine | 10.0mg/ml (10,000ppm) | > 240 min | Vincristine Sulfate
(Oncovin) | 1.0 mg/ml
(1,000 ppm) | >240 minutes | |
| | Idarubicin HCL | 1mg/ml (1,000ppm) | > 240 min | Do Not Use with Carmustine or Thiotepa | | | |
| | Ifosfamide | 50mg/ml (50,00ppm) | > 240 min | | | | |
| | Mechlorethamine
HCL | 1mg/ml (1,000ppm) | > 240 min | | | | |
| | MESNA | 100mg/ml
(100,000ppm) | > 240 min | | | | |
| | Methotrexate | 25mg/ml (25,000ppm) | > 240 min | | | | |
| | Mitomycin C | 0.5 mg/ml (500ppm) | > 240 min | | | | |
| | Mitoxantrone | 2mg/ml(2,000ppm) | > 240 min | | | | |
| | Trisenox | 1 mg/ml(1,000ppm) | > 240 min | | | | |
| | Vincristine Sulfate | 1 mg/ml (1.000ppm) | > 240 min | | | | |
7. Summary of Non-Clinical Testing
Physical performance qualities of the proposed device were evaluated per ASTM D6319- 19, 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
8
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE, CHINA
chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05(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
To summarize, the performance testing of the subject device were conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
ASTM D 6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D 6124-06 (2017) Standard Test Method for Residual Powder on Medical Gloves
ASTM D 5151-19 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D 6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
| Test
standard
followed | Test
conducted | Acceptance criteria | | | | Conclusion | |
|--------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------|--------------------------------------|-------|--------|------------|------|
| | | S | M | L | XL | | |
| ASTM D6319-19 | Physical
Dimensions | Length (mm) | ≥220 | | ≥230 | pass | |
| | | Width (mm) ±10 | 80±10 | 95±10 | 110±10 | 120±10 | pass |
| | | Thickness
Finger
Palm | ≥0.05 mm | | | | pass |
| ASTM D6319-19 | Physical
properties | Before Aging | Tensile ≥14Mpa; Elongation ≥
500% | | | | pass |
| | | After Aging | Tensile ≥14Mpa; Elongation ≥
400% | | | | pass |
| | | | | | | | |
| ASTM D6319-19
Test method in
accordance with
ASTM D5151-19 | Watertight
ness Test
for detection
of holes | Batch size=35000, sample 125
≤7 | | | | pass | |
| | | | | | | | |
| | | | | | | | |
| ASTM standard
D 6319-19
Test method
in
accordance with
D6124-06(2017) | Powder
Residual | ≤2 (mg/glove) | | | | pass | |
| | | | | | | | |
| | | | | | | | |
9
K212735(Page 6 / 7)
XINGYU MEDICAL TECH CO.,LTD.
NO.2189 YAOQIAN ROAD, GAOMI ECONOMIC DEVELOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE,
CHINA
| ASTM D 6978-
05(2019) | Chemotherapy
Drugs Tested
with Minimum
Breakthrough
Detection
Time | Chemotherapy Drug | Concentration | Breakthrough
time |
|--------------------------|-----------------------------------------------------------------------------------|------------------------------------|---------------------------|--------------------------|
| | | Carmustine (BCNU) | 3.3mg/ml (3,300ppm) | 47.9
(68.2,47.9,69.3) |
| | | Cyclophosphamide
(Cytoxan) | 20.0mg/ml (20,000ppm) | > 240 min |
| | | Doxorubicin HCl | 2.0 mg/ml (2,000ppm) | > 240 min |
| | | Etoposide | 20.0 mg/ml
(20,000ppm) | > 240 min |
| | | Fluorouracil | 50.0 mg/ml
(50,000ppm) | > 240 min |
| | | Paclitaxel | 6.0 mg/ml (6,000ppm) | > 240 min |
| | | ThioTepa | 10.0 mg/ml
(10,000ppm) | > 240 min |
| | | Bleomycin
Sulfate(Blenoxane) | 15mg/ml (15,000ppm) | > 240 min |
| | | Carboplatin | 10 mg/ml (10,000ppm) | > 240 min |
| | | Cisplatin | 1.0 mg/ml
(1,000ppm) | > 240 min |
| | | Cytarabine | 100mg/ml(100,000ppm) | > 240 min |
| | | Dacarbazine | 10.0mg/ml (10,000ppm) | > 240 min |
| | | Idarubicin HCl | 1mg/ml (1,000ppm) | > 240 min |
| | | Ifosfamide | 50mg/ml (50,00ppm) | > 240 min |
| | | Mechlorethamine
HCl | 1mg/ml (1,000ppm) | > 240 min |
| | | MESNA | 100mg/ml
(100,000ppm) | > 240 min |
| | | Methotrexate | 25mg/ml (25,000ppm) | > 240 min |
| | | Mitomycin C | 0.5 mg/ml (500ppm) | > 240 min |
| | | Mitoxantrone | 2mg/ml( 2,000ppm) | > 240 min |
| | | Trisenox | 1 mg/ml(1,000ppm) | > 240 min |
| | | Vincristine Sulfate | 1 mg/ml (1,000ppm) | > 240 min |
| | | Do Not Use with Carmustine (BCNU). | | |
8. Biocompatibility
The following tests were performed to evaluate the biocompatibility of the Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Acute Systemic Toxicity
| Test conducted | Standard | Acceptance
criteria | Result |
|------------------|--------------------------------------------------------------------------|---------------------------------|---------------------------------------------------------------------------------------------------------|
| Biocompatibility | Skin Irritation Test Extraction
Method ISO 10993-10: 2010 | non-irritation | Passes
Under the conditions of
the study, the subject
device is non-
irritation |
| | Skin sensitization the guinea
pig maximization ISO 10993-
10: 2010 | non- sensitization | Passes
Under the conditions of
the study, the subject
device is non-sensitization |
| | Acute Systemic Toxicity
Test ISO 10993-11: 2017 | non- acute systemic
toxicity | Passes
Under the conditions of
the study, the subject
device is non-acute
systemic toxicity |
10
9. Conclusion
Based on the nonclinical tests data, it can be concluded that the Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) is as safe, as effective, and performs as well as the predicate device, Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) by Medline Industries, Inc. K200960.