K Number
K221269
Device Name
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Date Cleared
2022-07-27

(86 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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)
Device Description
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl 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 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.
More Information

Not Found

No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML technology.

No.
The device is described as a disposable glove intended to prevent contamination between patient and examiner, primarily for examination and chemotherapy purposes, not for treating a disease or condition.

No

Explanation: The device is described as a disposable glove intended to prevent contamination between a patient and an examiner. It does not perform any diagnostic functions or provide information about a patient's medical condition.

No

The device description clearly indicates it is a physical glove made of nitrile, intended to be worn on the hand. It describes physical properties, dimensions, and performance testing related to material properties and resistance to chemicals, not software functionality.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states the device is a glove worn on the hand to prevent contamination between patient and examiner. Its primary function is a barrier.
  • Intended Use: The intended use is for medical purposes as a barrier, not for analyzing biological specimens.
  • Testing: While the gloves are tested for resistance to chemicals (chemotherapy drugs and Fentanyl Citrate), this testing is related to their barrier function and safety for the user, not for diagnosing a condition in a patient.

The device described is a medical device, specifically a Class I Patient Examination Glove and Specialty Chemotherapy Glove, but it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Product codes (comma separated list FDA assigned to the subject device)

LZA, LZC, ODO

Device Description

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl 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 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.

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:

  • ASTM D6319- 19 for Physical Dimensions (Length, Palm Width, Thickness): Pass
  • ASTM D6319- 19 and ASTM D412-16(2021) for Physical Properties (Tensile Strength and Elongation): Pass
  • ASTM D6319- 19 and ASTM D5151-19 for Water leak test: Pass (AQL 2.5)
  • ASTM D6319- 19 and ASTM D6124-06 (2017) for Powder Residue: Pass (Max 2mg/glove)
  • ASTM D6978-05 (2019) for Permeation by Chemotherapy Drugs: Pass (refer to table 1 for specific minimum breakthrough detection times for various drugs)
  • ISO 10993-10:2010 for Irritation and Skin Sensitization: Is non-sensitization and Non-irritation
  • ISO 10993-5:2009 for Cytotoxicity: showed potential toxicity to L929 cells. (Cytotoxicity concern was addressed by acute systematic toxicity testing.)
  • ISO 10993-11:2017 for Acute systemic toxicity study: no evidence of systemic toxicity.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Minimum Breakthrough Detection Time (BDT) for various chemotherapy drugs and Fentanyl Citrate, ranging from 11.1 minutes (Carmustine) to >240 minutes for most tested substances.
Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% and after aging 400%), Watertight (AQL 2.5), Powder-Content (≤ 2 mg per glove).

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.

K192954

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

0

Image /page/0/Picture/0 description: The image 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.

July 27, 2022

Better Care Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue, Chino, CA 91710, USA Chino, California 91710

Re: K221269

Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: April 18, 2022 Received: May 2, 2022

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, 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) K221269

Device Name

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentany) 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 using ASTM D6978-05(2019)

Chemotherapy DrugMinimum Breakthrough Detection Time (BDT) in Minutes
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)11.1
Chloroquine 50mg/ml (50,000ppm)>240
Cisplatin 1mg/ml (1,000 ppm)>240
Cyclophosphamide 20mg/ml (20,000 ppm)>240
Cyclosporin 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
Epirubicin HCL, 2 mg/ml (2,000 ppm)>240
Etoposide, 20 mg/ml (20,000 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)21.6
Topotecan, 1mg/ml (1,000ppm)>240
Trisenox, 1mg/ml (1,000ppm)>240
Velcade, 1mg/ml (1,000ppm)>240
Vincristine Sulfate, 1mg/ml (1,000ppm)>240
Fentanyl Citrate Injection (100 mcg/2ml)>240
Please note that the following drugs have extremely low permeation times:

3

Carmustine:11.1 minutes
Thio Tepa:21.6 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)

X 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

510K Summary

The assigned 510(K) numbers: K221269 Date Prepared: July 22, 2022

1. Owner's Identification:

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: kathyliu@hongrayusa.com or fdareg@hongray.com.cn

2. Name of the Device:

Trade / Product Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO Classification Panel: General Hospital Device Class: Class I

3. Predicate Device Information:

Comfort Rubber Gloves Industries Sdn. Bhd. Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)

4. Device Description:

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl 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 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.

5. Indications for Use:

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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)

5

Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

510K Summary

The following chemicals have been tested with these gloves:

Chemotherapy DrugMinimum Breakthrough Detection Time (BDT)in Minutes
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)11.1
Chloroquine 50mg/ml (50,000ppm)>240
Cisplatin 1mg/ml (1,000 ppm)>240
Cyclophosphamide 20mg/ml (20,000 ppm)>240
Cyclosporin 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
Epirubicin HCL, 2 mg/ml (2,000 ppm)>240
Etoposide, 20 mg/ml (20,000 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)21.6
Topotecan, 1mg/ml (1,000ppm)>240
Trisenox, 1mg/ml (1,000ppm)>240
Velcade, 1mg/ml (1,000ppm)>240
Vincristine Sulfate, 1mg/ml (1,000ppm)>240
Fentanyl Citrate Injection (100 mcg/2ml)>240

6

Fuqian Xi Road, West district of Shenze, Industrial Base,

Shenze County, Hebei, 050000, China

510K Summary

*Please note that the following drugs have extremely low permeation times: Carmustine: 11.1 minutes, Thio Tepa: 21.6 minutes Warning: Do not use with Carmustine and Thio Tepa.

6. Comparison of Subject Device and Predicate Device:

General Comparison Table:
Proposed Device
K221269Predicate Device
K192954Comparison
Trade NamePowder Free Nitrile
Examination Gloves (Blue),
Tested for Use with
Chemotherapy Drugs and
Fentanyl CitrateBlue Colored, Power Free Nitrile
Examination Gloves Tested for
Use with Chemotherapy Drugs
and Fentanyl CitrateSimilar
Product CodeLZA, LZC, QDOLZA, LZC,QDOSame
Regulation Number21 CFR 880.625021 CFR 880.6250Same
ClassIISame
Indications for UsePowder Free Nitrile
Examination Gloves (Blue),
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate 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
D6978Blue Colored, Powder Free Nitrile
Examination Gloves, Non-sterile,
and Tested for Use with
Chemotherapy Drugs and Fentanyl
Citrate 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.
Glove was tested for use with
Chemotherapy Drugs and Fentanyl
Citrate as per ASTM D6978Similar
MaterialNitrileNitrileSame
Powder or Powder FreePowder FreePowder FreeSame
ColorBlueBlueSame
Single useSingle useSingle useSame
Chemotherapy Drugs
and Fentanyl Citrate
ClaimSee below comparison tableSee below comparison tableSee below
comparison
table
Technological Characteristic Comparison Table:
Technological
CharacteristicsProposed Device
K221269Predicate Device
K192954Comparison
LengthMinimum 230mmMinimum 240mmSimilar
Palm Width (size) (mm)
XS70±1070±10Same
S80±1080±10Same
M95±1095±10Same
L110±10110±10Same
XL120±10120±10Same
XXL130±10N/ADifferent
Thickness(mm)
FingerMinimum 0.05Minimum 0.05Same
PalmMinimum 0.05Minimum 0.05Same
Tensile Strength, Before
Aging14MPa, min14MPa, minSame
Ultimate Elongation,
Before Aging500%, min500%, minSame
Tensile Strength, After
Accelerated Aging14MPa, min14MPa, minSame
Ultimate Elongation, After
Accelerated Aging400%, min400%, minSame
Watertight (1000ml)21 CFR 800.20
ASTM D5151
AQL 2.521 CFR 800.20
ASTM D5151
AQL 2.5Same
Powder-Content≤ 2 mg per glove≤ 2 mg per gloveSame
10993-10:2010 Skin
Irritation StudyUnder the conditions of
the study, not an irritantUnder the conditions of the
study, the subject device is
non-irritatingSame
10993-10:2010 Maximization
Sensitization StudyUnder the conditions of the
study, not a sensitizerUnder the conditions of the
study, the subject device is
non sensitizationSame
10993-5:2009 Cytotoxicity
TestUnder the conditions of this
study, the test article extract
showed potential toxicity to
L929 cells.
Cytotoxicity concern was
addressed by acute systematic
toxicity testing.Exhibits severe cytotoxicity
reactivity at 100%, and 66%
extract concentrations and
no cytotoxicity reactivity at
44%, 30%, 20% and 15%
extract concentrations under
the condition of this test.
Cytotoxicity concern wasSame
addressed by acute
systematic toxicity testing.
ISO 10993-11:2017
Acute Systemic toxicity studyUnder the conditions of this
study, there was no evidence
of systemic toxicity.Under the conditions of the
study, the subject showed no
adverse biological reaction.Same

7

Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

510K Summary

Technological Characteristic Comparison Table:

8

Fuqian Xi Road, West district of Shenze, Industrial Base,

Shenze County, Hebei, 050000, China

510K Summary

Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:

| Tested Chemotherapy Drug and

ConcentrationMinimum BDT (Minutes)Comparison
Proposed Device
K221269Predicate Device
K192954
Bleomycin Sulfate 15mg/ml (15000 ppm)>240N/ADifferent
Busulfan 6mg/ml (6,000 ppm)>240N/ADifferent
Carboplatin 10mg/ml (10,000 ppm)>240N/ADifferent
Carmustine (BCNU)3.3 mg/ml (3,300 ppm)11.118.2Similar
Chloroquine 50mg/ml (50,000ppm)>240N/ADifferent
Cisplatin 1mg/ml (1,000 ppm)>240>240Same
Cyclophosphamide 20mg/ml (20,000 ppm)>240>240Same
Cyclosporin 100 mg/ml (100,000 ppm)>240N/ADifferent
Cytarabine HCL, 100 mg/ml (100,000 ppm)>240N/ADifferent
Dacarbazine 10 mg/ml (10,000 ppm)>240>240Same
Daunorubicin HCL, 5 mg/ml (5,000 ppm)>240N/ADifferent
Docetaxel , 10 mg/ml (10,000 ppm)>240N/ADifferent
Doxorubicin HCL, 2 mg/ml (2,000 ppm)>240>240Same
Epirubicin HCL, 2 mg/ml (2,000 ppm)>240N/ADifferent
Etoposide, 20 mg/ml (20,000 ppm)>240>240Same
Fludarabine, 25 mg/ml (25,000 ppm)>240N/ADifferent
Fluorouracil, 50mg/ml (50,000ppm)>240>240Same
Gemcitabine, 38mg/ml (38,000ppm)>240N/ADifferent
Idarubicin HCL, 1mg/ml (1,000ppm)>240N/ADifferent
Ifosfamide, 50mg/ml (50,000ppm)>240N/ADifferent
Irinotecan, 20mg/ml (20,000ppm)>240N/ADifferent
Mechlorethamine HCI, 1mg/ml (1,000ppm)>240N/ADifferent
Melphalan, 5mg/ml (5,000ppm)>240N/ADifferent
Methotrexate, 25mg/ml (25,000ppm)>240N/ADifferent
Mitomycin C, 0.5mg/ml (500ppm)>240N/ADifferent
Mitoxantrone HCL, 2mg/ml (2,000ppm)>240N/ADifferent
Oxaliplatin, 5mg/ml (5,000ppm)>240N/ADifferent
Paclitaxel, 6mg/ml (6,000ppm)>240>240Same
Paraplatin, 10mg/ml (10,000ppm)>240N/ADifferent
Retrovir, 10mg/ml (10,000ppm)>240N/ADifferent

9

Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

510K Summary

Rituximab, 10mg/ml (10,000ppm)>240N/ADifferent
Thio Tepa, 10mg/ml (10,000ppm)21.657.3Similar
Topotecan, 1mg/ml (1,000ppm)>240N/ADifferent
Trisenox, 1mg/ml (1,000ppm)>240N/ADifferent
Velcade, 1mg/ml (1,000ppm)>240N/ADifferent
Vincristine Sulfate, 1mg/ml (1,000ppm)>240N/ADifferent
Fentanyl Citrate Injection (100 mcg/2ml)>240>240Same

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:

MethodologyTest PerformedAcceptance CriteriaResults
ASTM D6319- 19Physical Dimensions
LengthMinimum 230mm for all
sizesPass
ASTM D6319- 19Physical Dimensions
Palm WidthXS: 70±10mm
S: 80±10mm
M: 95±10mm
L:110±10mm
XL: 120±10mm
XXL: 130±10mmPass
ASTM D6319- 19Physical Dimensions
ThicknessFinger: 0.05mm (min)
Palm: 0.05mm (min)Pass
ASTM D6319- 19
ASTM D412-16(2021)Physical PropertiesTensile Strength (Min14
MPa) and Elongation
(Before Aging 500% and
after aging 400%) Min
AQL 2.5 (ISO 2859-1)Pass
ASTM D6319- 19
ASTM D5151-19Water leak testAQL 2.5 (ISO 2859-1)Pass
ASTM D6319- 19
ASTM D6124-06
(2017)Powder ResidueMax 2mg/glovePass
ASTM D6978-05
(2019)Permeation by
Chemotherapy DrugsRefer the above table 1Pass
ISO 10993-10:2010Irritation and Skin
SensitizationSkin sensitization and
Skin irritationIs non-sensitization
and Non-irritation
ISO 10993-5:2009CytotoxicityCytotoxicity reactivityshowed potential
toxicity to L929
cells.
ISO 10993-11:2017Acute systemic toxicity
studySubject showed no adverse
biological reactionno evidence of
systemic toxicity.

● ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

10

Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China

510K Summary

  • . 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 10993-10:2010 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

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 predicated device.