(30 days)
Not Found
No
The summary describes a standard medical examination glove and its physical and chemical resistance properties. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies and key metrics are focused on material properties and safety, not algorithmic performance.
No
The device, Nitrile Examination Gloves, is intended to prevent contamination and is tested for resistance to chemotherapy drugs and fentanyl, indicating it is a barrier device for protection rather than a device for treatment or therapy.
No
Explanation: The device is described as "Nitrile Examination Gloves," intended for preventing contamination between patient and examiner and tested for use with chemotherapy drugs and fentanyl citrate. Its function is a barrier and protective measure, not to identify or diagnose any medical condition.
No
The device is a physical glove made of nitrile compound, not software. The description details its material, physical properties, and testing against standards for physical performance and chemical resistance.
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 finger. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and material of the glove, and its testing for chemical permeation. It does not describe any components or mechanisms for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, test strips, or analytical components described.
- Testing: The testing described (ASTM standards for physical properties and chemical permeation) is relevant to the barrier function and chemical resistance of a glove, not to diagnostic performance.
- Predicate Device: The predicate device is also a sterile nitrile examination glove with chemotherapy drug claims, reinforcing that this device falls under the category of personal protective equipment (PPE) and not IVDs.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not perform any such tests.
N/A
Intended Use / Indications for Use
The glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3mg/ml) | 54.3 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 196.7 |
| Methotrexate (25mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Cytarabine HCL (100mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
Minimum BDT (Minutes) Opioid Drug Fentanyl Citrate Injection (100mcg/2mL) >240 Caution: Please note that the following drugs have low permeation times: Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner
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 performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:
| Referenced standards | Test Performed/Prupose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL | 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 | Pass |
| ASTM D6319- 19 ASTM D5151-19 | Freedom from holes | G-I, AQL 2.5 | Pass |
| ASTM D6319- 19 ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Chemotherapy Drugs, Opioid Drug Permeation | Refer the above tables | Pass |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute 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 contains the logo for 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2023
Grand Work Plastic Products Co., Ltd. Wu Yuli General Manager Donggao Industrial Zone Zanhuang, Hebei 050000 China
Re: K232039
Trade/Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO, OPJ
Dear Wu Yuli:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on August 9, 2023. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, OHT4: Office of Surgical and Infection Control Devices, at: 301-796-2261, or Bifeng. Qian@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
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
1
Image /page/1/Picture/0 description: The image contains two logos. The first logo is the Department of Health & Human Services logo. The second logo is the FDA U.S. Food & Drug Administration logo.
Grand Work Plastic Products Co., Ltd. Wu Yuli General Manager Donggao Industrial Zone Zanhuang, Hebei 050000 China
Re: K232039
Trade/Device Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: July 5, 2023 Received: July 10, 2023
Dear Wu Yuli:
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 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
2
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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Allan-Guan -S
For 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
3
Indications for Use
510(k) Number (if known) K232039
Device Name
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
The glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3mg/ml) | 54.3 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 196.7 |
| Methotrexate (25mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Cytarabine HCL (100mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
Minimum BDT (Minutes) Opioid Drug Fentanyl Citrate Injection (100mcg/2mL) >240 Caution: Please note that the following drugs have low permeation times: Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes
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.
4
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5
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K232039
Date Prepared: August 09, 2023
1. Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
Contact: Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
2. Name of the Device:
Trade Name: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA, LZC, QDO, OPJ Device Class: Class I
3. Predicate Device Information:
Grand Work Plastic Products Co., Ltd. Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (K220250) Classification Panel: 880 General Hospital and Personal Use Product Code: LZA, LZC Device Class: Class I
4. Device Description:
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).
Specification for subject device: Acceptance Criteria Results Items Length Minimum 230mm All size ≥290 XS: 70±10mm 76-78mm Palm Width S: 80±10mm 86-88 mm
6
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| M:95±10mm | 96 -98mm | |
|---|---|---|
| L:110±10mm | 106-108 mm | |
| XL: 120±10mm | 116-118 mm | |
| XXL: 130±10mm | 126-128 mm | |
| Thickness | Palm: 0.05mm (min) | 0.09-0.11mm |
| Finger: 0.05mm (min) | 0.13-0.14mm | |
| Tensile Strength, Before Aging | 14MPa, min | 15.8-20.8 MPa |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 15.6-19.8 MPa |
| Ultimate Elongation, Before Aging | 500%, min | 500-560% |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 400-500% |
| Freedom from holes | G-I, AQL 2.5 | Meet AQL2.5 |
| requirements | ||
| Powder-Content | 240 | |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 | |
| Etoposide (20mg/ml) | >240 | |
| Fluorouracil (50mg/ml) | >240 | |
| Paclitaxel (6mg/ml) | >240 | |
| Thiotepa (10mg/ml) | 196.7 | |
| Methotrexate (25mg/ml) | >240 | |
| Cisplatin (1mg/ml) | >240 | |
| Vincristine Sulfate (1.0 mg/ml) | >240 | |
| Cytarabine HCL (100mg/ml) | >240 | |
| Mitoxantrone (2.0 mg/ml) | >240 | |
| Mitomycin C (0.5 mg/ml) | >240 | |
| Ifosfamide (50.0 mg/ml) | >240 | |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
7
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| Opioid Drug | Minimum BDT (Minutes) |
|---|---|
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
Caution: Please note that the following drugs have low permeation times: Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes
7. Comparison of Technological Characteristics Between the Subject Device and Predicate Device:
| Items | Predicate Device
K220250 | Subject Device
K232039 | Result of
comparison |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Trade Name | Sterile Powder Free Nitrile
Examination Gloves (Blue),
Tested for Use with
Chemotherapy Drugs | Sterile Powder Free Nitrile
Examination Gloves (Blue),
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate | Different* |
| Product Code | LZA, LZC | LZA, LZC, OPJ, QDO | Different* |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Description | Sterile Examination glove | Sterile Examination glove | Same |
| Indications for Use | Sterile Powder Free Nitrile
Examination Gloves (Blue),
Tested for Use with
Chemotherapy Drugs 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. In addition
these gloves were tested for use
with Chemotherapy drugs in
accordance with ASTM D6978. | The 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. In
addition these gloves were
tested for use with
Chemotherapy drugs and
fentanyl citrate in accordance
with ASTM D6978. | Different* |
| Powder or Powder
Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Material use | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Sterility | Sterile | Sterile | Same |
| Single use | Single use | Single use | Same |
| Chemotherapy
Drug Permeation
Claim | See below comparison table | See below comparison table | / |
*This different is support with test report and will be indicated on labeling.
Chemotherapy Permeation Comparison Claim:
| Tested Chemotherapy Drug and Concentration | Minimum BDT (Minutes) | | Result of
comparison |
|--------------------------------------------|-----------------------------|---------------------------|-------------------------|
| | Predicate Device
K220250 | Subject Device
K232039 | |
8
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| Carmustine (BCNU) (3.3mg/ml) | 54.3 | 54.3 | Same |
|---|---|---|---|
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Paclitaxel (6mg/ml) | >240 | >240 | Same |
| Thiotepa (10mg/ml) | 196.7 | 196.7 | Same |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Vincristine Sulfate (1.0 mg/ml) | >240 | >240 | Same |
| Cytarabine HCL (100mg/ml) | >240 | >240 | Same |
| Mitoxantrone (2.0 mg/ml) | >240 | >240 | Same |
| Mitomycin C (0.5 mg/ml) | >240 | >240 | Same |
| Ifosfamide (50.0 mg/ml) | >240 | >240 | Same |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 | >240 | Same |
| Opioid Drug and Concentration | Minimum BDT (Minutes) | | Result of
comparison |
|-----------------------------------------|-----------------------------|---------------------------|-------------------------|
| | Predicate Device
K220250 | Subject Device
K232039 | |
| Fentanyl Citrate Injection (100mcg/2mL) | / | >240 | Different* |
*This different is support with test report and will be indicated on labeling.
Dimensions and Performance Comparison Table:
| Technological | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Characteristics | K232039 | K220250 | |
| Length | Minimum 230mm | Minimum 230mm | Same |
| 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 | 130±10 | Same |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before | 14MPa, min | 14MPa, min | Same |
| Aging | |||
| Ultimate Elongation, | 500%, min | 500%, min | Same |
| Before Aging | |||
| Tensile Strength, After | 14MPa, min | 14MPa, min | Same |
| Accelerated Aging | |||
| Ultimate Elongation, | 400%, min | 400%, min | Same |
| After Accelerated Aging | |||
| Freedom from holes | In accordance with ASTM D | In accordance with ASTM D | Same |
9
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| | 5151-19, following ASTM
D6319-19, G-I, AQL 2.5 | 5151-19, following ASTM
D6319-19, G-I, AQL 2.5 | |
|-----------------|---------------------------------------------------|---------------------------------------------------|------|
| Residual Powder | ≤2 mg per glove | ≤2 mg per glove | Same |
8. Summary of Non-Clinical Testing
Non-clinical tests were performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:
| Referenced standards | Test Performed/Prupose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions Length | Minimum 220mm for size XS | |
| and S, 230mm for size M, L, XL | 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 | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D5151-19 | Freedom from holes | G-I, AQL 2.5 | Pass |
| ASTM D6319- 19 | |||
| ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Chemotherapy Drugs, Opioid | ||
| Drug Permeation | Refer the above tables | Pass | |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin | |
| irritation | Is non- | ||
| sensitization and | |||
| Non-irritation | |||
| ISO 10993-11:2017 | Acute systemic toxicity | ||
| study | Subject showed no adverse | ||
| biological reaction | no evidence of | ||
| acute systemic | |||
| toxicity. |
8. Summary of Clinical Information:
No clinical testing was submitted for the subject device.
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.