(238 days)
No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML capabilities.
No
The device description states it is a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner," indicating a protective barrier function, not a therapeutic one.
No
The device is a medical glove intended for preventing contamination, not for diagnosing medical conditions.
No
The device description clearly states it is a physical glove made of nitrile, intended to be worn on the hand. It is a tangible hardware device, not software.
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 to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and testing related to its barrier function and resistance to chemicals, not on any diagnostic capabilities.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. This glove serves a protective function during medical interactions.
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO, OPJ
Device Description
Powder Free Nitrile Examination Glove (Grev) Tested for Use with Chemotherapy Drugs and Fentany) Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, 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
examiner's hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: ASTM D6319-19
Test Performed: Physical Dimensions Length, Physical Dimensions Palm Width, Physical Dimensions Thickness, Physical Properties, Water leak test, Powder Residue
Acceptance Criteria: Length: Minimum 220mm for size XS and S, 230mm for size M, L, XL; Palm Width: XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm; Thickness: Finger: 0.05mm (min), Palm: 0.05mm (min); Physical Properties: Tensile Strength (Min14 Mpa) and Elongation (Before Aging 500% and after aging 400%) Min; Water leak test: G-I, AQL 2.5 (ISO 2859-1); Powder Residue: Max 2mg/glove.
Results: All Pass.
Methodology: ASTM D6978-05 (2019)
Test Performed: Permeation by Chemotherapy Drugs
Acceptance Criteria: Refer the above table 1 (Chemotherapy Drug and Concentration vs. Minimum Breakthrough Detection Time).
Results: Pass.
Methodology: ISO 10993-10:2010
Test Performed: Irritation and Skin Sensitization
Acceptance Criteria: No Skin sensitization and Skin irritation
Results: Is non-sensitization and Non-irritation.
Methodology: ISO 10993-5:2009
Test Performed: Cytotoxicity
Acceptance Criteria: No Cytotoxicity reactivity
Results: showed potential toxicity to L929 cells.
Methodology: ISO 10993-11:2017
Test Performed: Acute systemic toxicity study
Acceptance Criteria: Subject showed no adverse biological reaction
Results: 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.
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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 7, 2023
Better Care Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K223713
Trade/Device Name: Powder Free Nitrile Examination Glove (Grey) 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 Dated: July 6, 2023 Received: July 6, 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 (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 -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
Enclosure
2
Indications for Use
510(k) Number (if known) K223713
Device Name
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
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.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Arsenic Trioxide (1 mg/ml) | >240 |
| Azacitidine (25 mg/ml) | >240 |
| Bendamustine HCL (5 mg/ml) | >240 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Bortezomib (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 13.9 |
| Cetuximab (2 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Cytarabine (Cytosine) (100 mg/ml) | >240 |
| Cytovene (10 mg/ml) | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | >240 |
| Daunorubicin HCL (5 mg/ml) | >240 |
| Decitabine (5-Aza-2'-deoxycytidine) (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Epirubicin HCL(Ellence) (2 mg/ml) | >240 |
| Eribulin Mesylate (0.5 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| 5-Fluorouracil (50 mg/ml) | >240 |
| Fulvestrant (50 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCL (20 mg/ml) | >240 |
| Mechlorethamine HCL (1 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin-C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Pemetrexed (25 mg/ml) | >240 |
3
| Pertuzumab (30 mg/ml) | >240 |
|---|---|
| Raltitrexed monohydrate (0.5 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Temsirolimus (25 mg/ml) | >240 |
| Thiotepa (10 mg/ml) | 44.4 |
| Topotecan HCL (1 mg/ml) | >240 |
| Trastuzumab (21 mg/ml) | >240 |
| Trisenox (1 mg/ml) | >240 |
| Vinblastine (1 mg/ml) | >240 |
| Vincrinstine Sulfate (1 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |
| Zoledronic Acid (0.8 mg/ml) | >240 |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time (Minutes) |
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 13.9 minutes, Thio Tepa: 44.4 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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4
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510(K) SUMMARY
The assigned 510(K) numbers: K223713 Date Prepared: August 2, 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: fdareg@hongray.com.cn or kathyliu(@hongrayusa.com
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Non-Powdered Patient Examination Glove Specialty Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Primary Predicate Device: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue) Tested for Use with Chemotherapy Drugs and Fentany! Citrate (K221269)
Reference device:
O & M Halyard, Inc.
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves (K191230)
This reference device is being used to support inclusion of additional chemotherapy drugs that were not tested in the predicate.
4. Device Description:
Powder Free Nitrile Examination Glove (Grev) Tested for Use with Chemotherapy Drugs and Fentany) Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, 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.
5
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
The following chemicals have been tested with these gloves: Table 1
| Chemotherapy Drug
and Concentration | Minimum Breakthrough Detection
Time
(Minutes) |
|-----------------------------------------------|-----------------------------------------------------|
| Arsenic Trioxide (1 mg/ml) | >240 |
| Azacitidine (25 mg/ml) | >240 |
| Bendamustine HCL (5 mg/ml) | >240 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Bortezomib (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 13.9 |
| Cetuximab (2 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Cytarabine (Cytosine) (100 mg/ml) | >240 |
| Cytovene (10 mg/ml) | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | >240 |
| Daunorubicin HCL (5 mg/ml) | >240 |
| Decitabine (5-Aza-2'-deoxycytidine) (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 |
| Epirubicin HCL(Ellence) (2 mg/ml) | >240 |
| Eribulin Mesylate (0.5 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| 5-Fluorouracil (50 mg/ml) | >240 |
| Fulvestrant (50 mg/ml) | >240 |
| Gemcitabine (38 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCL (20 mg/ml) | >240 |
| Mechlorethamine HCL (1 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin-C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Pemetrexed (25 mg/ml) | >240 |
| Pertuzumab (30 mg/ml) | >240 |
| Raltitrexed monohydrate (0.5 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Temsirolimus (25 mg/ml) | >240 |
| Thiotepa (10 mg/ml) | 44.4 |
| Topotecan HCL (1 mg/ml) | >240 |
| Trastuzumab (21 mg/ml) | >240 |
| Trisenox (1 mg/ml) | >240 |
| Vinblastine (1 mg/ml) | >240 |
| Vincrinstine Sulfate (1 mg/ml) | >240 |
| Vinorelbine (10 mg/ml) | >240 |
| Zoledronic Acid (0.8 mg/ml) | >240 |
6
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time
(Minutes) |
|----------------------------------------------------------------------------|--------------------------------------------------|
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | >240 |
*Please note that the following drugs have extremely low permeation times: Carmustine: 13.9 minutes, Thio Tepa: 44.4 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 of the proposed and predicate devices. General Comparison Table:
| | Subject Device
K223713 | Predicate Device
K221269 | Reference Device
K191230 | Comparison |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Trade Name | Powder Free Nitrile
Examination Glove (Grey)
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate | Powder Free Nitrile
Examination Glove (Blue)
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate | Halyard Sterling* Nitrile
Powder-Free Exam
Gloves, Halyard Sterling
SG* Nitrile Sensi-Guard
Powder-Free Exam
Gloves | Similar |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC,QDO | LZC | Different * |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Indications for Use | The device is a disposable
device intended for medical
purposes that is worn on the
examiner's hand to prevent
contamination between
patient and examiner.
These gloves were tested for
use with chemotherapy drugs
and Fentanyl listed on the
label. | The device is a disposable
device intended for medical
purposes that is worn on the
examiner's hand to prevent
contamination between
patient and examiner.
These gloves were tested for
use with chemotherapy drugs
and Fentanyl listed on the
label. | The device is a
disposable device
intended for medical
purposes that is worn on
the examiner's hand to
prevent contamination
between patient and
examiner.
These gloves were tested
for use with
chemotherapy drugs
listed on the label. | Same as
K221269* |
| Material | Nitrile | Nitrile | Nitrile | Same |
| Powder or Powder
Free | Powder Free | Powder Free | Powder Free | Same |
| Color | Grey | Blue | Grey | Different
from
K221269**
Same as
K191230 |
| Single use | Single use | Single use | Single use | Same |
| Dermal Irritation
ISO 10993-10 | Based on the criteria, the test
article extracts were
considered negligible
irritants. | Under the conditions of the
study, not an irritant | Based on the criteria and
conditions of the study,
the test article was
considered nonirritating | Same |
| Dermal Sensitization
ISO 10993-10 | Based on the criteria
and conditions of the
study, the test article is
classified as a non-sensitizer | Under the conditions of the
study, not a sensitizer | Based on the criteria and
conditions of the study,
the test article showed
no evidence of causing
delayed dermal contact
sensitization | Same |
| Cytotoxicity Test
ISO 10993-5 | / | 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. | / | Different
from
K221269
Same as
K191230 |
| Acute Systemic
Toxicity
ISO 10993-11 | Based on the criteria, the test
article meets the requirements | Under the conditions of this
study, there was no evidence
of systemic toxicity. | No mortality of evidence
of systemic toxicity
from the extracts | Same |
| Chemotherapy Drugs
and Fentanyl Citrate
Claim | See below comparison table | See below comparison table | See below comparison
table | / |
| Technological
Characteristics | Subject Device
K223713 | Predicate Device
K221269 | Reference Device
K191230 | Comparison |
| Physical Dimension | | | | |
| Length | Minimum 230mm | Minimum 230mm | Minimum 230mm | 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 |
| Thickness(mm) | | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Physical Property | | | | |
| 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 |
| Watertight (1000ml) | G-I, AQL2.5 | G-I, AQL2.5 | G-I, AQL2.5 | Same |
| Powder-Content | ≤2 mg per glove | ≤2 mg per glove | ≤2 mg per glove | Same |
7
Better Care Plastic Technology Co., Ltd
Fuqian Xi Road, West district of Shenze, Industrial Base,
8
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
- QDO and OPJ, both designated for Medical Gloves with Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs, the subject device added the product code OPJ as per reguirements but does not raise questions of safety and effectiveness.
** 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:
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug and | Minimum Breakthrough Detection Time (Minutes) | Comparison | ||
|---|---|---|---|---|
| Concentration | Subject Device | Reference Device | Predicate Device | With |
| K223713 | K191230 | K221269 | K191230 | |
| Arsenic Trioxide (1 mg/ml) | >240 | >240 | / | Same |
| Azacitidine (25 mg/ml) | >240 | >240 | / | Same |
| Bendamustine HCL (5 mg/ml) | >240 | >240 | / | Same |
| Bleomycin sulfate (15 mg/ml) | >240 | >240 | >240 | Same |
| Bortezomib (1 mg/ml) | >240 | >240 | / | Same |
| Busulfan (6 mg/ml) | >240 | >240 | >240 | Same |
| Carboplatin (10 mg/ml) | >240 | >240 | >240 | Same |
| Carfilzomib (2 mg/ml) | >240 | >240 | / | Same |
| Carmustine (3.3 mg/ml) | 13.9 | 14.8 | 11.1 | Similar |
| Cetuximab (2 mg/ml) | >240 | >240 | / | Same |
| Cisplatin (1 mg/ml) | >240 | >240 | >240 | Same |
| Cyclophosphamide (20 mg/ml) | >240 | >240 | >240 | Same |
| Cytarabine (Cytosine) (100 mg/ml) | >240 | >240 | >240 | Same |
| Cytovene (10 mg/ml) | >240 | >240 | / | Same |
| Dacarbazine (DTIC) (10 mg/ml) | >240 | >240 | >240 | Same |
| Daunorubicin HCL (5 mg/ml) | >240 | >240 | >240 | Same |
| Decitabine (5-Aza-2'-deoxycytidine) (5 mg/ml) | >240 | >240 | / | Same |
| Docetaxel (10 mg/ml) | >240 | >240 | >240 | Same |
| Doxorubicin Hydrochloride (2 mg/ml) | >240 | >240 | >240 | Same |
| Epirubicin HCL(Ellence) (2 mg/ml) | >240 | >240 | >240 | Same |
| Eribulin Mesylate (0.5 mg/ml) | >240 | >240 | / | Same |
| Etoposide (Toposar) (20 mg/ml) | >240 | >240 | >240 | Same |
| Fludarabine (25 mg/ml) | >240 | >240 | >240 | Same |
| 5-Fluorouracil (50 mg/ml) | >240 | >240 | >240 | Same |
| Fulvestrant (50 mg/ml) | >240 | >240 | / | Same |
| Gemcitabine (38 mg/ml) | >240 | >240 | >240 | Same |
| Idarubicin (1.0 mg/ml) | >240 | >240 | >240 | Same |
| Ifosfamide (50 mg/ml) | >240 | >240 | >240 | Same |
| Irinotecan HCL (20 mg/ml) | >240 | >240 | >240 | Same |
| Mechlorethamine HCL (1 mg/ml) | >240 | >240 | >240 | Same |
| Melphalan (5 mg/ml) | >240 | >240 | >240 | Same |
| Methotrexate (25 mg/ml) | >240 | >240 | >240 | Same |
| Mitomycin-C (0.5 mg/ml) | >240 | >240 | >240 | Same |
| Mitoxantrone (2 mg/ml) | >240 | >240 | >240 | Same |
| Oxaliplatin (2 mg/ml) | >240 | >240 | >240 | Same |
| Paclitaxel (6 mg/ml) | >240 | >240 | >240 | Same |
| Paraplatin (10 mg/ml) | >240 | >240 | >240 | Same |
| Pemetrexed (25 mg/ml) | >240 | >240 | / | Same |
| Pertuzumab (30 mg/ml) | >240 | >240 | / | Same |
| Raltitrexed monohydrate (0.5 mg/ml) | >240 | >240 | / | Same |
| Retrovir (10 mg/ml) | >240 | >240 | >240 | Same |
| Rituximab (10 mg/ml) | >240 | >240 | >240 | Same |
| Temsirolimus (25 mg/ml) | >240 | >240 | / | Same |
| Thiotepa (10 mg/ml) | 44.4 | 23.9 | 21.6 | Similar |
| Topotecan HCL (1 mg/ml) | >240 | >240 | >240 | Same |
| Trastuzumab (21 mg/ml) | >240 | >240 | / | Same |
| Trisenox (1 mg/ml) | >240 | >240 | >240 | Same |
| Vinblastine (1 mg/ml) | >240 | >240 | / | Same |
| Vincrinstine Sulfate (1 mg/ml) | >240 | >240 | >240 | Same |
| Vinorelbine (10 mg/ml) | >240 | >240 | / | Same |
| Zoledronic Acid (0.8 mg/ml) | >240 | >240 | / | Same |
| Tested Fentanyl Citrate and Concentration | ||||
| Fentanyl Citrate Injection (100mcg/2mL) | >240 | / | >240 | Different* |
| Simulated Gastric Acid Fluid/Fentanyl Citrate | ||||
| Injection Mix 50/50 Solution | >240 | / | / | Different* |
9
Fuqian Xi Road, West district of Shenze, Industrial Base,
10
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this different does not raise questions of safety and effectiveness.
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 | Pass | ||
| ASTM D6319- 19 | Physical Dimensions Palm | ||
| Width | XS: 70±10mm | ||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L:110±10mm | |||
| XL: 120±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 | Water leak test | G-I, 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 1 | 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 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. ●
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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
- 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 10993-10:2010 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
-
- Summary of Clinical Testing: Not provided 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 predicated device.