(91 days)
Not Found
No
The summary describes a physical medical device (gloves) and its performance characteristics based on standard testing, with no mention of AI, ML, or related computational technologies.
No.
The device's intended use is to prevent contamination between patient and examiner, which is a protective measure rather than a therapeutic one.
No
The device is described as a disposable glove intended to prevent contamination between patient and examiner, and is classified as a Class I Patient Examination Glove. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical glove made of biodegradable nitrile, which is a hardware component. The testing described also focuses on physical properties and chemical resistance, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device's Intended Use: The intended use of this glove is to be worn on the examiner's hand to prevent contamination between the patient and the examiner. This is a barrier device used on the body (or in contact with the body and the environment), not for testing specimens from the body.
- Device Description: The description focuses on the physical properties of the glove, its materials, and its resistance to certain substances. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies and key metrics relate to the glove's physical integrity, barrier properties, and biocompatibility. They do not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for IVDs.
This device is a medical glove, which is a type of medical device, but it does not fit the definition of an In Vitro Diagnostic device.
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).
Black Glove:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml {3,300 ppm) | 23.0 |
| 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) | 45.9 |
| Fentanyl Citrate | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine: 23.0 minutes, Thie Tepa: 45.9 minutes
Warning: Do not use with Carmustine and Thiotepa.
Green Glove:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml {3,300 ppm) | 15.4 |
| 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) | 34.4 |
| Fentanyl Citrate | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
| *Please note that the following drugs have extremely low permeation times: Carmustine: 15.4 minutes, Thio Tepa: 34.4 minutes |
Warning: Do not use with Carmustine and Thiotepa.
Product codes
LZA, LZC, QDO, OPJ
Device Description
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, 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. The glove has biodegradation property within landfills tested per ASTM D5511.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
on the 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
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 220mm for size XS-S Minimum 230mm for size M-XXL | 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) Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319- 19 ASTM D5151-19 | Freedom from holes | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19 ASTM D6124-06 (2017) | Powder Residue | ≤ 2 mg per glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs and Fentanyl Citrate | Refer the above table | Pass |
| ISO 10993-10 &23:2021 | Irritation and Skin Sensitization | Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | 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 acute systemic toxicity. |
| ISO 11737-1:2018 | Open box bioburden study | No significant increase in bioburden | Pass |
Key Metrics
Minimum Breakthrough Detection Time for chemotherapy drugs and Fentanyl Citrate.
Permeation by Chemotherapy Drugs and Fentanyl Citrate was measured.
Physical Dimensions (Length, Palm Width, Thickness), Physical Properties (Tensile Strength, Elongation), Freedom from holes (AQL), Powder Residue.
Biocompatibility tests: In vitro Cytotoxicity, Acute Systemic Toxicity Test, Dermal Sensitization, Primary Skin Irritation.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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.
October 11, 2023
Better Care Plastic Technology Co., Ltd Ms. Zhu Chunyan General Manager Fugian Xi Road. West district of Shenze Industrial Base Shenze County, Hebei, China 050000
Re: K232070
Trade/Device Name: Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO, OPJ Dated: September 14, 2023 Received: September 14, 2023
Dear Ms. Zhu Chunyan :
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
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) K232070
Device Name
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
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).
| Black Glove: | |
|---|---|
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
| Carmustine 3.3 mg/ml {3,300 ppm) | 23.0 |
| 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) | 45.9 |
| Fentanyl Citrate | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine: 23.0 minutes, Thie Tepa: 45.9 minutes
Warning: Do not use with Carmustine and Thiotepa.
| Green Glove: | |
|---|---|
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
| Carmustine 3.3 mg/ml {3,300 ppm) | 15.4 |
| 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) | 34.4 |
| Fentanyl Citrate | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
*Please note that the following drugs have extremely low permeation times: Carmustine: 15.4 minutes, Thio Tepa: 34.4 minutes
Warning: Do not use with Carmustine and Thiotepa.
4
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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5
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510(k) Summary
The assigned 510(K) numbers: K232070 Date Prepared: October 10, 2023
1. Owner's Identification:
Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
Contact: Ms. Zhu Chunyan / General Manager Tel: 909-590-1611 Email: janicema@hongrayusa.com or fdareg@hongray.com.cn
2. Device Identification:
Trade / Product Name: Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) Common Name: Non-Powdered Patient Examination Glove Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Hartalega NGC SDN. BHD. Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (K223437)
4. Device Description:
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, 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. The glove has biodegradation property within landfills tested per ASTM D5511.
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. The gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978- 05(2019).
6
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510(k) Summary
Black glove:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in
Minutes |
|---------------------------------------|---------------------------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 23.0 |
| 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) | 45.9 |
| Fentanyl Citrate | Minimum Breakthrough
Detection Time in Minutes |
|----------------------------------------|---------------------------------------------------|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
*Please note that the following drugs have extremely low permeation times: Carmustine: 23.0 minutes, Thio Tepa: 45.9 minutes Warning: Do not use with Carmustine and Thiotepa.
Green glove:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in
Minutes |
|---------------------------------------|---------------------------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 15.4 |
| 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) | 34.4 |
| Fentanyl Citrate | Minimum Breakthrough
Detection Time in Minutes |
|----------------------------------------|---------------------------------------------------|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
7
Fuqian Xi Road, West district of Shenze, Industrial Base,
Shenze County, Hebei, 050000, China
510(k) Summary
*Please note that the following drugs have extremely low permeation times: Carmustine: 15.4 minutes, Thio Tepa: 34.4 minutes Warning: Do not use with Carmustine and Thiotepa.
6. Comparison of Subject Device and Predicate Device:
The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs & Fentanyl Citrate of the subject and predicate devices.
| Characteristics and
Parameters | Subject Device | Predicate Device
K223437 | Discussion |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Biodegradable Nitrile Examination
Gloves Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate (Black, Green) | Biodegradable Nitrile Powder Free
Examination Glove Tested for Use
with Chemotherapy Drugs and
Fentanyl Citrate (Fusion Colour) | Similar |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| 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) | A non-sterile disposable device
intended for medical purpose that is
worn on the examiner's hand to
prevent contamination between
patient and examiner. It is also tested
to be used against Chemotherapy
Drugs and Fentanyl Citrate.
The gloves were tested for use with
chemotherapy drugs as per ASTM
D6978-05 (Reapproved 2019)
Standard Practice for Assessment of
Resistance of Medical Gloves to
Permeation by Chemotherapy Drugs. | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Black, Green | Fusion Colour | Different |
| Design | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | • Single Use
• Non-sterile
• Powder-Free
• Ambidextrous | Same |
| Chemotherapy Drugs
and Fentanyl Citrate
Claim | See below comparison table | See below comparison table | / |
General Comparison Table:
8
Fuqian Xi Road, West district of Shenze, Industrial Base,
Shenze County, Hebei, 050000, China
510(k) Summary
| Sterility | Non-sterile | Non-sterile | Same |
|---|---|---|---|
| ----------- | ------------- | ------------- | ------ |
** The finished subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color does not raise questions of safety and effectiveness.
Technological Characteristic Comparison Table:
| Technological
Characteristics | Subject Device | | Predicate Device
K223437 | Comparison |
|-------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------|
| Length | Black | Green | | |
| | XS: ≥ 220 mm
S: ≥ 220 mm
M: ≥ 230 mm
L: ≥ 230 mm
XL: ≥ 230 mm
XXL: ≥ 230 mm | XS: ≥ 220 mm
S: ≥ 220 mm
M: ≥ 230 mm
L: ≥ 230 mm
XL: ≥ 230 mm
XXL: ≥ 230 mm | XS: ≥ 220 mm
S: ≥ 220 mm
M: ≥ 230 mm
L: ≥ 230 mm
XL: ≥ 230 mm
XXL: ≥ 230 mm | Same |
| Palm Width (size) (mm) | | | | |
| XS | 70±10 | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | 120±10 | Same |
| XXL | 130±10 | 130±10 | 130±10 | Same |
| Thickness(mm) | | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before
Aging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,
Before Aging | 500%, min | 500%, min | 500%, min | Same |
| Tensile Strength, After
Accelerated Aging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,
After Accelerated Aging | 400%, min | 400%, min | 400%, min | Same |
| Freedom from holes | Meets ASTM D5151-
19: AQL 2.5 | Meets ASTM
D5151-19: AQL 2.5 | Meets ASTM D5151-19:
AQL 1.5 | Meet ASTM
D6319 and
similar |
| Powder residue | Meets ASTM D6124-
06 (2017): | Meets ASTM
D6124-06 (2017): | Meets ASTM D6124-06
(2017): | Same |
| | Residual Powder: ≤ 2
mg per glove | Residual Powder: ≤ 2
mg per glove | Residual Powder: ≤ 2 mg
per glove | |
9
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
| 510(k) Summary | ||||
|---|---|---|---|---|
| In vitro Cytotoxicity | ||||
| ISO 10993-5 | Under the conditions | |||
| of this study, the test | ||||
| article showed | ||||
| potential toxicity to | ||||
| L929 cells. | Under the | |||
| conditions of this | ||||
| study, the test | ||||
| article showed | ||||
| potential toxicity to | ||||
| L929 cells. | The neat extract was found | |||
| to be cytotoxic | Same | |||
| Acute Systemic Toxicity | ||||
| Test | ||||
| ISO 10993-11 | Under the conditions | |||
| of this study, there was | ||||
| no evidence of acute | ||||
| systemic toxicity from | ||||
| the test article. | Under the conditions | |||
| of this study, there | ||||
| was no evidence of | ||||
| acute systemic | ||||
| toxicity | ||||
| from the test article. | Under the conditions of this | |||
| study, the device showed no | ||||
| evidence of acute systemic | ||||
| toxicity | Same | |||
| Dermal Sensitization | ||||
| ISO 10993-10 | Under the conditions | |||
| of this study, the test | ||||
| article showed no | ||||
| significant evidence of | ||||
| causing skin | ||||
| sensitization | Under the conditions | |||
| of this study, the test | ||||
| article showed no | ||||
| significant evidence | ||||
| of causing skin | ||||
| sensitization | Under the conditions of the | |||
| study, the device is not a | ||||
| sensitizer | Same | |||
| Primary Skin Irritation | ||||
| ISO 10993-23 | The test result | |||
| showed that the | ||||
| response of the test | ||||
| article was | ||||
| categorized as | ||||
| negligible under the | ||||
| test condition. | The test result | |||
| showed that the | ||||
| response of the test | ||||
| article was | ||||
| categorized as | ||||
| negligible under the | ||||
| test condition. | Under the conditions of the | |||
| study, the device is not an | ||||
| irritant | Same | |||
| Shelf-Life Expiry | ||||
| ASTM D7160-16 | 3 years | 3 years | 3 years | Same |
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Minimum BDT (Minutes) | ||||
|---|---|---|---|---|
| Tested Chemotherapy Drug and | ||||
| Concentration | Subject Device | Predicate Device | ||
| K223437 | Comparison | |||
| Black | Green | |||
| Carmustine 3.3 mg/ml (3,300 ppm) | 23.0 | 15.4 | 12.1 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 45.9 | 34.4 | 37.8 | Similar |
| 5-Azacytidine (25.0 mg/ml) | / | / | >240 | Different |
| Carboplatin (10.0 mg/ml) | / | / | >240 | Different |
| Doxetacel (10.0 mg/ml) | / | / | >240 | Different |
| Epirubicin (2.0 mg/ml) | / | / | >240 | Different |
10
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
| 510(k) Summary | ||||
|---|---|---|---|---|
| Gemcitabine (38.0 mg/ml) | / | / | >240 | Different |
| Ifosfamide (50.0 mg/ml) | / | / | >240 | Different |
| Irinotecan (20.0 mg/ml) | / | / | >240 | Different |
| Mitomycin C (0.5 mg/ml) | / | / | >240 | Different |
| Mitoxantrone (2.0 mg/ml) | / | / | >240 | Different |
| Oxalipatin (5.0 mg/ml) | / | / | >240 | Different |
| Vincristine Sulfate (1.0 mg/ml) | / | / | >240 | Different |
| Oncovin (1.0 mg/ml) | / | / | >240 | Different |
| Vinorelbine (10.0mg/ml) | / | / | >240 | Different |
| Tested Opiod Drug and Concentration | Minimum BDT (Minutes) | Comparison | ||
|---|---|---|---|---|
| Subject Device | Predicate Device | |||
| K223437 | ||||
| Black | Green | |||
| Fentanyl Citrate Injection, 100mcg/2mg | >240 | >240 | >240 | Same |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this difference does not raise questions of safety and effectiveness of subject device.
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 220mm for size XS-S | ||
| Minimum 230mm for size M-XXL | 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) | |
| Elongation (Before Aging 500% | |||
| and after aging 400%) Min | Pass | ||
| ASTM D6319- 19 | |||
| ASTM D5151-19 | Freedom from holes | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19 | |||
| ASTM D6124-06 (2017) | Powder Residue | ≤ 2 mg per glove | Pass |
| ASTM D6978-05 (2019) | Permeation by | ||
| Chemotherapy Drugs | |||
| and Fentanyl Citrate | Refer the above table | Pass | |
| ISO 10993-10 &23:2021 | Irritation and Skin | ||
| Sensitization | Skin sensitization and Skin | ||
| irritation | Is non-sensitization | ||
| and Non-irritation |
11
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
| 510(k) Summary | |||
|---|---|---|---|
| ISO 10993-5:2009 | Cytotoxicity | 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 acute | ||
| systemic toxicity. | |||
| ISO 11737-1:2018 | Open box bioburden | ||
| study | No significant increase in bioburden | Pass |
● 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 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 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Sensitization. ●
- ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 23: Tests For Skin Irritation. ●
- 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 .
- ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products.
- Biodegradability is not a medical claim and therefore was not reviewed by FDA. ●
8. Clinical Performance Data
Not applicable.
9. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safective, and performs as well as or better than the legally marketed predicate device (K223437).