(95 days)
No
The 510(k) summary describes a physical examination glove and its performance characteristics based on standard material testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The primary purpose of the glove is to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one.
No
The device is described as a disposable glove intended to prevent contamination between patient and examiner, and is tested for resistance to chemotherapy drugs and Fentanyl Citrate. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical glove made of biodegradable nitrile, intended to be worn on the hand. It describes physical properties, testing for chemotherapy drug permeation, and biocompatibility, all indicative of a hardware device. There is no mention of software functionality.
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 worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and barrier capabilities of the glove, including testing for resistance to chemotherapy drugs and Fentanyl Citrate. These are related to protection and safety, not diagnosis.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for the diagnosis of a disease or condition.
- Performance Studies and Key Metrics: The performance studies and key metrics are focused on the physical integrity, barrier properties, and biocompatibility of the glove. They do not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC.
In summary, the device is a medical glove intended for protection and contamination prevention, not for performing diagnostic tests on samples taken from the human body.
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)
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 and Fentanyl Citrate (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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:
- ASTM D6319-19: Physical Dimensions Length (Pass), Physical Dimensions Palm Width (Pass), Physical Dimensions Thickness (Pass), Physical Properties (Tensile Strength (Min14 Mpa) and Elongation (Before Aging 500% and after aging 400%) Min) (Pass)
- ASTM D5151-19: Water leak test (AQL 2.5 (ISO 2859-1)) (Pass)
- ASTM D6124-06 (2017): Powder Residue (Max 2mg/glove) (Pass)
- ASTM D6978-05 (2019): Permeation by Chemotherapy Drugs (Refer the above table in Section 5) (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 (There is no increase in bioburden levels) (Pass)
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
September 8, 2023
Syntex Healthcare Products Co., Ltd. % Kathy Liu Project Manager Hongray(USA) Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K231643
Trade/Device Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (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: June 5, 2023 Received: August 7, 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.
Allan Guan -S
For Bifeng Oian, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231643
Device Name
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum BDT (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) | 12.9 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 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 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 35.6 |
| 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 |
3
| Fentanyl Citrate | Minimum BDT Minutes |
|---|---|
| Fentanyl Citrate Injection | (100 mcg/2ml) >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 12.9 minutes, Thio Tepa: 35.6 minutes
Warning: Do not use with Carmustine and Thio Tepa.
Type of Use (Select one or both, as applicable)
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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4
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
Date Prepared: September 07, 2023
1. Owner's Identification:
Mr. Qiao Zhiqiang Syntex Healthcare Products Co., Ltd No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, 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 janicema(@hongrayusa.com
2. Name of the Device:
Trade / Product Name: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (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 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 and Fentanyl Citrate (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.
5. Indications for Use:
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent
5
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (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) | 12.9 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 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 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 35.6 |
| 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 |
6
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
| Fentanyl Citrate | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 12.9 minutes, Thio Tepa: 35.6 minutes
Warning: Do not use with Carmustine and Thio Tepa.
6. Comparison of Subject Device and Predicate Devices:
The following tables are summaries of the technological characteristics, biocompatibility and testing for the subject Device and predicate devices.
General Comparison Table:
| | Subject Device
K231643 | Predicate Device
K200581 | Reference Device
K221269 | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Trade Name | Biodegradable Nitrile
Powder Free Examination
Gloves Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate(Blue) | Biodegradable Nitrile
Powder Free Examination
Gloves Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate (Blue) | Powder Free Nitrile
Examination Glove
(Blue) Tested for Use
with Chemotherapy
Drugs and Fentanyl
Citrate | Similar |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC,QDO | LZA, LZC,QDO | Different* |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Indications for
Use | Biodegradable Nitrile
Powder Free Examination
Gloves Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate (Blue) is a
disposable device intended
for medical purposes that is
worn on the examiner's
hand to prevent
contamination between
patient and examiner.
Gloves have been tested for
use with chemotherapy drugs
and Fentanyl Citrate using
ASTM D6978-05(2019) | Biodegradable Nitrile
Powder Free Examination Gloves
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate (Blue) is a
patient medical exam glove
which is a disposable device
intended for medical purpose
that is worn on the examiner's
hand or finger to prevent
contamination between
examiner and patient.
It is also tested to be used
against chemotherapy drugs
and Fentanyl Citrate | 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. | Same as
K200581 |
| Material | Nitrile | Nitrile | Nitrile | Same |
7
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
| Powder or
| Powder Free | Powder Free | Powder Free | Powder Free | Same |
|---|---|---|---|---|
| Color | Blue | Blue | Blue | Same |
| Single use | Single use | Single use | Single use | Same |
| Chemotherapy | ||||
| Drugs and | ||||
| Fentanyl Citrate | ||||
| Claim | See below comparison | |||
| table | See below comparison table | See below comparison | ||
| table | / | |||
| Biodegradation | ||||
| Properties | Biodegradable | Biodegradable | / | Same as |
| K200581 |
- 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 requirements but does not raise questions of safety and effectiveness.
Technological Characteristic Comparison Table:
| Technological
Characteristics | Subject
Device
K231643 | Predicate Device
K200581 | Reference Device
K221269 | Comparison |
|----------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|------------|
| Physical Dimension | | | | |
| Length | Minimum 220mm for
sizes XS and S,
230mm for size M-
XXL | Minimum 220mm for
sizes XS and S,
230mm for size M-
XXL | Minimum 220mm
for sizes XS and S,
230mm for size M-
XXL | 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 |
| 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 |
8
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
| 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 |
| In vitro Cytotoxicity | ||||
| ISO 10993-5 | The test article extract | |||
| showed potential | ||||
| toxicity to L929 cells. | N/A | The test article | ||
| extract showed | ||||
| potential toxicity to | ||||
| L929 cells. | Same as | |||
| K221269 | ||||
| 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 | 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 the study, the device | ||||
| is not a sensitizer | Under the conditions | |||
| of the study, the device | ||||
| is not a sensitizer | Under the | |||
| conditions of the | ||||
| study, the device is | ||||
| not a sensitizer | 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 | Under the | |||
| conditions of the | ||||
| study, the device | ||||
| is not an irritant | Same |
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug and
Concentration | Minimum Breakthrough Detection Time
(Minutes) | | | Comparison |
|-----------------------------------------------------|--------------------------------------------------|-----------------------------|-----------------------------|--------------------|
| | Subject Device
K231643 | Predicate Device
K200581 | Reference Device
K221269 | |
| 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) | 12.9 | 21.4 | 11.1 | Similar |
| Chloroquine 50mg/ml (50,000ppm) | >240 | / | >240 | Same as
K221269 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | Same |
| | | | | |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 | / | >240 | Same as
K221269 |
| 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 |
| 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 |
| Retrovir, 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) | 35.6 | 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 Citrate Injection (100 mcg/2ml) | >240 | >240 | >240 | Same |
9
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
10
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling.
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 sizes XS and S, 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) 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 | Refer the above table in Section 5 | 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 | There is no increase in bioburden levels | 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 Resistance of Medical Gloves to Permeation by
11
No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China
510K Summary K231643
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 10: 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.
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.