(126 days)
No
The summary describes a physical medical glove and its material properties and testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The document states the device is intended to prevent contamination between patient and examiner, which is a preventative measure, not a therapeutic one.
No
The device is a glove intended to prevent contamination and protect against certain drugs; it does not diagnose medical conditions.
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 clearly states the glove is for preventing contamination between patient and examiner during medical procedures. This is a barrier function, not a diagnostic function performed in vitro (outside 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 describe any components or functions related to analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical and chemical resistance properties of the glove, not on diagnostic accuracy or performance metrics like sensitivity, specificity, etc., which are crucial for IVDs.
The testing for chemotherapy drugs and Fentanyl Citrate resistance relates to the glove's protective function for the user, not to diagnosing a condition in the patient.
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 or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate and select other drugs in accordance with ASTM D6978.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (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, Fentanyl Citrate and select other drugs 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
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (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:
- ASTM D6319-19 (Physical Dimensions: Length, Palm Width, Thickness) - Pass
- ASTM D6319-19 / ASTM D412-16(2021) (Physical Properties: Tensile Strength and Elongation) - Pass
- ASTM D6319-19 / ASTM D5151-19 (Water leak test) - Pass
- ASTM D6319-19 / ASTM D6124-06(2017) (Powder Residue) - Pass
- ASTM D6978-05(2019) (Permeation by Chemotherapy Drugs, Fentanyl Citrate and select other drugs) - Pass (refer to tables for specific breakthrough times)
- ISO 10993-10 & 23:2021 (Irritation and Skin Sensitization) - Is non-sensitization and Non-irritation
- ISO 10993-5:2009 (Cytotoxicity) - showed potential toxicity to L929 cells.
- ISO 10993-11:2017 (Acute systemic toxicity study) - no evidence of acute systemic toxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include physical dimensions (length, palm width, thickness), tensile strength, elongation, water leak test AQL, powder residue (Max 2mg/glove), minimum breakthrough detection time for specific chemotherapy drugs, fentanyl citrate, and other drugs, and biocompatibility results (skin sensitization, skin irritation, cytotoxicity, acute systemic toxicity).
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.
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.
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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 on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 4, 2023
Better Care Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray(USA) Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K231567
Trade/Device Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, QDO Dated: September 5, 2023 Received: September 5, 2023
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 (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.
1
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" (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 QS 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,
Image /page/1/Picture/7 description: The image shows the text "Allan Guan -S" in a large, sans-serif font. The text is black and appears to be the main focus of the image. The background is plain, with a faint watermark-like design that is barely visible behind the text.
For Bifeng Qian, M.D., Ph.D. Assistant Director
2
DHT4B: Division of Infection Control and Plastic and Reconstructive 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) K231567
Device Name
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
Indications for Use (Describe)
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, Fentanyl Citrate and select other drugs in accordance with ASTM D6978.
| Chemotherapy Drugs | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Azacytidine (Vidaza) 25 mg/ml (25000ppm) | >240 |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 11.8 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 33.5 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate (Oncovin), 1mg/ml (1,000ppm) | >240 |
| Vinorelbine, 10 mg/ml (10000ppm) | >240 |
Fentanyl citrate & other drugs Fentanyl Citrate Injection (100mcg/2mL) Minimum Breakthrough Detection Time (BDT) in Minutes
4
| Chloroquine 50mg/ml (50,000ppm) | >240 |
|---|---|
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 11.8 minutes, Thio Tepa: 33.5 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
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5
The assigned 510(K) numbers: K231567
Date Prepared: October 4, 2023
1. Owner's Identification:
Mrs. Zhu Chunyan 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: janicema@hongrayusa.com or fdareg(@hongray.com.cn
2. Name of the Device:
Trade / Product Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, OPJ, QDO Classification Panel: General Hospital Device Class: Class I
3. Predicate and Reference Device Information:
Primary Predicate Device Hartalega NGC SDN. BHD. Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K200581)
Reference device: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K221269)
4. Device Description:
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (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, Fentanyl Citrate and select other drugs 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 or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978. The following chemicals have been tested with these gloves:
6
| Chemotherapy Drug | Minimum Breakthrough Detection Time
(BDT) in Minutes |
|--------------------------------------------------|---------------------------------------------------------|
| Azacytidine (Vidaza) 25 mg/ml (25000ppm) | >240 |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 11.8 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 33.5 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate (Oncovin), 1mg/ml (1,000ppm) | >240 |
| Vinorelbine, 10 mg/ml (10000ppm) | >240 |
| Fentanyl citrate & other drugs | Minimum Breakthrough Detection Time
(BDT) in Minutes |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
7
*Please note that the following drugs have extremely low permeation times: Carmustine: 11.8 minutes, Thio Tepa: 33.5 minutes Warning: Do not use with Carmustine and Thio Tepa.
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, and select other drugs of the proposed and predicate devices. General Comparison Table:
| | Subject Device
K231567 | Predicate Device
K200581 | Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Trade Name | Biodegradable Nitrile Powder Free
Examination Gloves Tested for
Use with Chemotherapy Drugs ,
Fentanyl Citrate, and select other
drugs (Blue) | Biodegradable Nitrile Powder Free
Examination Gloves Tested for Use
with Chemotherapy Drugs and
Fentanyl Citrate (Blue) | Same |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC,QDO | 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 or finger to
prevent contamination between
patient and examiner. In
addition these gloves were
tested for use with
Chemotherapy drugs, Fentanyl
Citrate, and select other drugs
in accordance with ASTM
D6978. | Biodegradable Nitrile Powder Free
Examination Gloves Tested for Use
with Chemotherapy Drugs and
Fentanyl Citrate (Blue) is a non-sterile
disposable device intended for medical
purpose that is worn on the examiner's
hand to prevent contamination between
examiner and patient.
It is also tested to be used against
chemotherapy drugs and Fentanyl
Citrate | Different* |
| Material | Nitrile | Nitrile | Same |
| Powder or Powder Free | Powder Free | Powder Free | Same |
| Color | Blue | Blue | Same |
| Single use | Single use | Single use | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Chemotherapy Drugs,
Fentanyl Citrate and
other drugs Claim | See below comparison
table | See below comparison table | / |
| Technological
Characteristics | Subject Device
K231567 | Predicate Device
K200581 | Comparison |
| Length | Meets ASTM D6319
Minimum 220mm for size XS
and S; 230mm for Size M, L, XL,
XXL | Meets ASTM D6319
Minimum 220mm for size
XS and S; 230mm for Size
M, L, XL, XXL | Same |
| Palm Width (size) (mm) | Meets ASTM D6319 | Meets ASTM D6319 | Same |
| 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) | Meets ASTM D6319 | Meets ASTM D6319 | Same |
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before Aging | Meets ASTM D6319
14MPa, min | Meets ASTM D6319
14MPa, min | Same |
| Ultimate Elongation,
Before Aging | Meets ASTM D6319
500%, min | Meets ASTM D6319
500%, min | Same |
| Tensile Strength, After
Accelerated Aging | Meets ASTM D6319
14MPa, min | Meets ASTM D6319
14MPa, min | Same |
| Ultimate Elongation, After
Accelerated Aging | Meets ASTM D6319
400%, min | Meets ASTM D6319
400%, min | Same |
| Watertight (1000ml) | Meets ASTM D6319
21 CFR 800.20
ASTM D5151 | Meets ASTM D6319
21 CFR 800.20
ASTM D5151 | Same |
| Powder-Content | Meets ASTM D6319
≤2 mg per glove | Meets ASTM D6319
≤2 mg per glove | Same |
| In vitro Cytotoxicity
ISO 10993-5 | The test article extract showed
potential toxicity to L929 cells. | NA | Different* |
| Dermal Sensitization
ISO 10993-10 | Under the conditions of the
study, the test article extract
showed no significant
evidence of causing skin
sensitization | Under the conditions of the
study, the device is not a
sensitizer | Same |
| Acute Systemic Toxicity Test
ISO 10993-11 | Under the conditions of this
study, the device showed no
evidence of acute systemic
toxicity | Under the conditions of this
study, the device showed no
evidence of acute systemic
toxicity | Same |
| Primary Skin Irritation
ISO 10993-23 | Under the conditions of the
study, the device is not an
irritant | Under the conditions of the
study, the device is not an
irritant | Same |
| Shelf-Life Expiry
ASTM D7160-16 | 3 Years | 3 Years | Same |
| ASTM D5511-18 biodegradable
Properties | biodegradable | biodegradable | Different** |
*This different is support with test report and will be indicated on labeling. So the differences do not impact the safety, effectiveness, and substantial equivalence of the subject device compared to the predicate.
Technological Characteristic Comparison Table:
8
9
*The Biocompatibility testing was successfully completed for the subject device, demonstrating that the difference does not raise different questions of safety and effectiveness and does not affect the substantial equivalence in effectiveness and safety.
**Biodegradability of subject device will be indicated on labeling and it is not a medical claim and therefore was not reviewed by FDA.
Chemotherapy Permeation Comparison:
| Tested Chemotherapy Drug and
Concentration | Subject
Device
K231567 | Primary
Predicate
Device
K200581 | Reference
Device
K221269 | Comparison |
|-----------------------------------------------|------------------------------|-------------------------------------------|--------------------------------|--------------------|
| Azacytidine (Vidaza) 25 mg/ml (25000ppm) | >240 | >240 | / | Same as
K200581 |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | / | >240 | Same as
K221269 |
| Busulfan 6mg/ml (6,000 ppm) | >240 | / | >240 | Same as
K221269 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 11.8 | 21.4 | 11.1 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same as
K221269 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | / | >240 | Same as
K221269 |
| Docetaxel, 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 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | / | >240 | Same as
K221269 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | / | >240 | Same as
K221269 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Irinotecan, 20mg/ml (20,000ppm) | >240 | >240 | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | / | >240 | Same as
K221269 |
| Melphalan, 5mg/ml (5,000ppm) | >240 | / | >240 | Same as
K221269 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 | Same |
10
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | >240 | Same |
|---|---|---|---|---|
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | / | >240 | Same as |
| K221269 | ||||
| Rituximab, 10mg/ml (10,000ppm) | >240 | / | >240 | Same as |
| K221269 | ||||
| Thio Tepa, 10mg/ml (10,000ppm) | 33.5 | 67.2 | 21.6 | Similar |
| Topotecan, 1mg/ml (1,000ppm) | >240 | / | >240 | Same as |
| K221269 | ||||
| Trisenox, 1mg/ml (1,000ppm) | >240 | / | >240 | Same as |
| K221269 | ||||
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 | / | >240 | Same as |
| K221269 | ||||
| Vincristine Sulfate (Oncovin), 1mg/ml | ||||
| (1,000ppm) | >240 | >240 | >240 | Same |
| Vinorelbine, 10 mg/ml (10000ppm) | >240 | >240 | / | Same as |
| K200581 |
Fentanyl and Select Other Drugs Permeation Comparison
| Fentanyl citrate & other drugs | Minimum Breakthrough Detection Time
(BDT) in Minutes | | | Comparison |
|------------------------------------------|---------------------------------------------------------|---------------------|---------------------|--------------------|
| | Subject
Device | Predicate
Device | Reference
Device | |
| | K231567 | K200581 | K221269 | |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 | Same |
| Chloroquine 50mg/ml (50,000ppm) | >240 | / | >240 | Same as
K221269 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same as
K221269 |
| Retrovir, 10mg/ml (10,000ppm) | >240 | / | >240 | Same as
K221269 |
Chemotherapy drugs and chemical as their minimum breakthrough time of subject device and "Gloves used for protection against chemotherapy drug exposure should be selected specifically for the type of chemicals used" will be listed on labeling, so the differences do not impact the safety, effectiveness, and substantial equivalence of the subject device compared to the predicate.
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 | ||
| and S; 230mm for Size M, L, XL, | |||
| XXL | Pass | ||
| ASTM D6319- 19 | Physical Dimensions | ||
| Palm Width | XS: 70 $\pm$ 10mm | ||
| S: 80 $\pm$ 10mm | |||
| M: 95 $\pm$ 10mm | |||
| L:110 $\pm$ 10mm | |||
| XL: 120 $\pm$ 10mm | Pass |
11
| XXL: 130 ±10mm | |||
|---|---|---|---|
| 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 (Min 14 Mpa) | |
| and Elongation (Before Aging | |||
| 500% and after aging 400%) | |||
| Min | 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, | |||
| Fentanyl Citrate and | |||
| select other drugs | Refer the above table 1 | 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. |
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 ●
- Biodegradability is not a medical claim and therefore was not reviewed by FDA
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 predicate device.