(12 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 is described as a disposable glove intended to prevent contamination between patient and examiner, not to provide therapeutic benefit to a patient.
No
The device description indicates that it is 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, not one used to obtain or interpret diagnostic information.
No
The device is a physical glove, not software. The description details material properties, physical dimensions, and performance testing related to a tangible product.
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 used during physical examination or procedures, not a device used to examine specimens from the human body in vitro (outside the body).
- Device Description: The description focuses on the physical properties and testing of the glove itself (material, size, strength, resistance to chemicals), not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The testing mentioned (ASTM D6978-05(2019) for chemotherapy drugs and Fentanyl Citrate) relates to the glove's barrier properties and safety for the user and patient in a clinical setting, not to in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.2 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 29.4 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Please note that the following drugs have extremely low permeation times: Carmustine: 11.2 minutes, Thio Tepa: 21.6 minutes * Warning: Do not use with Carmustine and Thio Tepa.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, ODO
Device Description
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
worn on the examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions Length | Minimum 230mm for all sizes | Pass |
| ASTM D6319- 19 | Physical Dimensions Palm Width | XS: 70±10mm | |
| S: 80±10mm | |||
| M: 95±10mm | |||
| L:110±10mm | |||
| XL: 120±10mm | |||
| XXL: 130±10mm | Pass | ||
| ASTM D6319- 19 | Physical Dimensions Thickness | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 MPa) and Elongation | |
| (Before Aging 500% and after aging 400%) Min | |||
| AQL 2.5 (ISO 2859-1) | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19 | |||
| ASTM D6124-06 | |||
| (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 | |||
| (2019) | Permeation by Chemotherapy Drugs | Refer the above table | Pass |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | No Cytotoxicity reactivity | showed potential toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of systemic toxicity |
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 27, 2022
Better Care Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K222449
Trade/Device Name: Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: August 10, 2022 Received: August 15, 2022
Dear Kathy Liu:
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.
Bifeng Qian, M.D., 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) K222449
Device Name
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.2 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 29.4 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Please note that the following drugs have extremely low permeation times: Carmustine: 11.2 minutes, Thio Tepa: 21.6 minutes * Warning: Do not use with Carmustine and Thio Tepa.
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)
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3
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
The assigned 510(K) numbers: _K222449
Date Prepared: August 10, 2022
1. Owner's Identification:
Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China Tel:86-311-66179668 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel:909-590-1611 Email: kathyliu@hongrayusa.com or fdareg@hongray.com.cn
2. Name of the Device:
Trade / Product Name: Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Comfort Rubber Gloves Industries Sdn. Bhd. Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)
4. Device Description:
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
The Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
4
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
The following chemicals have been tested with these gloves:
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT)
in Minutes |
|------------------------------------------|---------------------------------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.2 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 29.4 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
- Please note that the following drugs have extremely low permeation times:
Carmustine: 11.2 minutes, Thiotepa: 29.4 minutes
- Warning: Do not use with Carmustine and Thiotepa.
6. Comparison of Subject Device and Predicate Device:
General Comparison Table:
| | Proposed Device
K222449 | Predicate Device
K192954 | Comparison |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Nitrile Powder Free
Examination Gloves, Tested
For Use With Chemotherapy
Drugs And Fentanyl Citrate
(Dark Blue) | Blue Colored, Power Free Nitrile
Examination Gloves Tested for
Use with Chemotherapy Drugs
and Fentanyl Citrate | Similar |
| Product Code | LZA, LZC, QDO | LZA, LZC,QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
5
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
| Indications for Use | Nitrile Powder Free
Examination Gloves, Tested
For Use With Chemotherapy
Drugs And Fentanyl Citrate
(Dark Blue) is a disposable
device intended for medical
purposes that is worn on the
examiner's hand to prevent
contamination between patient
and examiner. Gloves have
been tested for use with
chemotherapy drugs and
Fentanyl Citrate using ASTM
D6978 | Blue Colored, Powder Free Nitrile
Examination Gloves, Non-sterile,
and Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate is a patient medical exam
glove which is a disposable device
intended for medical purpose that
is worn on the examiner's hand or
finger to prevent contamination
between examiner and patient.
Glove was tested for use with
Chemotherapy Drugs and Fentanyl
Citrate as per ASTM D6978 | Similar | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------|
| | Material | Nitrile | Nitrile | Same |
| | Powder or Powder Free | Powder Free | Powder Free | Same |
| | Color | Dark Blue | Blue | Similar |
| | Single use | Single use | Single use | Same |
| | Chemotherapy Drugs
and Fentanyl Citrate
Claim | See below comparison table | See below comparison table | See below
comparison
table |
Technological Characteristic Comparison Table:
| Technological
Characteristics | Proposed Device | Predicate Device
K192954 | Comparison |
|-----------------------------------|-----------------|-----------------------------|------------|
| Length | Minimum 230mm | Minimum 240mm | Similar |
| Palm Width (size) (mm) | | | |
| XS | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | Same |
| XXL | 130±10 | N/A | Different |
| Thickness(mm) | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before
Aging | 14MPa, min | 14MPa, min | Same |
6
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
| Ultimate Elongation,
| Before Aging | 500%, min | 500%, min | Same |
|---|---|---|---|
| Tensile Strength, After | |||
| Accelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, After | |||
| Accelerated Aging | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20 | ||
| ASTM D5151 | |||
| AQL 2.5 | 21 CFR 800.20 | ||
| ASTM D5151 | |||
| AQL 2.5 | Same | ||
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| 10993-10:2010 Skin | |||
| Irritation Study | Under the conditions of | ||
| the study, not an irritant | Under the conditions of the | ||
| study, the subject device is | |||
| non-irritating | Same | ||
| 10993-10:2010 Maximization | |||
| Sensitization Study | Under the conditions of the | ||
| study, not a sensitizer | Under the conditions of the | ||
| study, the subject device is | |||
| non sensitization | Same | ||
| 10993-5:2009 Cytotoxicity | |||
| Test | Under the conditions of this | ||
| study, the test article extract | |||
| showed potential toxicity to | |||
| L929 cells. | |||
| Cytotoxicity concern was | |||
| addressed by acute systematic | |||
| toxicity testing. | Exhibits severe cytotoxicity | ||
| reactivity at 100%, and 66% | |||
| extract concentrations and | |||
| no cytotoxicity reactivity at | |||
| 44%, 30%, 20% and 15% | |||
| extract concentrations under | |||
| the condition of this test. | |||
| Cytotoxicity concern was | |||
| addressed by acute | |||
| systematic toxicity testing. | Same | ||
| ISO 10993-11:2017 | |||
| Acute Systemic toxicity study | Under the conditions of this | ||
| study, there was no evidence | |||
| of systemic toxicity. | Under the conditions of the | ||
| study, the subject showed no | |||
| adverse biological reaction. | Same |
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug and
| Concentration | Minimum BDT (Minutes) | Comparison | |
|---|---|---|---|
| Proposed Device | Predicate Device | ||
| K192954 | |||
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.2 | 18.2 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same |
7
Fuqian Xi Road, West district of Shenze, Industrial Base,
Shenze County, Hebei, 050000, China
510K Summary
| Methotrexate, 25mg/ml (25,000ppm) | >240 | N/A | Different |
|---|---|---|---|
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 29.4 | 57.3 | Similar |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
7. Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions Length | Minimum 230mm for all sizes | Pass |
| ASTM D6319- 19 | Physical Dimensions Palm Width | XS: 70±10mm | |
| S: 80±10mm | |||
| M: 95±10mm | |||
| L:110±10mm | |||
| XL: 120±10mm | |||
| XXL: 130±10mm | Pass | ||
| ASTM D6319- 19 | Physical Dimensions Thickness | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 MPa) and Elongation | |
| (Before Aging 500% and after aging 400%) Min | |||
| AQL 2.5 (ISO 2859-1) | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19 | |||
| ASTM D6124-06 | |||
| (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 | |||
| (2019) | Permeation by Chemotherapy Drugs | Refer the above table | Pass |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | No Cytotoxicity reactivity | showed potential toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of systemic toxicity |
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. .
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ●
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical ●
8
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
Gloves
- . ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation . by Chemotherapy Drugs.
- 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
- . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
8. Clinical Performance Data
N/A
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.