Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device description clearly states its purpose is to prevent contamination between patient and examiner, and it is worn as a glove. This falls under barrier protection, not therapeutic intervention.

Diagnostic

No

Explanation: The device described is a medical glove intended to prevent contamination, not to diagnose any medical condition or disease. Its purpose is protective barrier, not diagnostic measurement or analysis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical, disposable glove made of nitrile, intended to be worn on the hand. It undergoes physical and chemical testing, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to prevent contamination between a patient and an examiner by being worn on the hand or fingers. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
Device Description: The description focuses on the physical characteristics and material of the glove, and its use as a barrier.
Performance Studies: The performance studies listed are related to the physical properties of the glove (watertightness, tensile strength, etc.), biocompatibility, and resistance to chemotherapy drugs. These are all relevant to a barrier device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.

The testing for use with chemotherapy drugs is a performance characteristic of the glove as a barrier, not a diagnostic function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

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

LZA, LZC

Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands or fingers

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner / medical purpose

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)

Biocompatibility Testing:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization. Results: Not an irritant or a sensitizer.
- ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. Results: Device extract is cytotoxic.
- ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity. Results: Did not show acute systemic toxicity in vivo.
Performance Testing (Bench):
- Physical performance qualities evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
- Permeation testing conducted according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, for chemotherapy drug labeling claim.
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves. Results: 0.15-0.19mg/Pass.
- ASTM D5151-19, Standard Test Method for Detection of Holes in -Medical Gloves. Results: 0/125/Pass.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves i for Medical Application. Results for physical dimensions: Length ≥ 230/Pass; Width S: 85-89/Pass, M: 94-97/Pass, L: 100-104/Pass, XL:110-113/Pass; Thickness Finger: 0.16-0.18/Pass, Palm: 0.11-0.12/Pass.
- ASTM D 6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Breakthrough Detection Time for Carmustine (BCNU) was 33.5 Minutes and Thio Tepa was 62.6 Minutes. All other tested chemotherapy drugs had breakthrough times > 240 Minutes.
- ASTM D412 Physical properties: Before Aging Tensile Strength 16.5-33.1MPa/Pass, Ultimate Elongation 500-585%/Pass; After Aging Tensile Strength 14.1-28.3MPa/Pass, Ultimate Elongation 482-555%/Pass.

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

Length (mm): S:≥220; M/L/XL: ≥230
Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10
Thickness (mm): Finger: ≥0.05; Palm: ≥0.05
Freedom from Holes: AQL=2.5
Powder Content: 0.15-0.19 mg per glove
Before Aging: Tensile Strength 14MPa, min; Ultimate Elongation 500% min
After Aging: Tensile Strength 14MPa, min; Ultimate Elongation 400% min
Breakthrough Detection Time for Carmustine (BCNU): 33.5 Minutes
Breakthrough Detection Time for Cisplatin: > 240 Minutes
Breakthrough Detection Time for Cyclophosphamide (Cytoxan): > 240 Minutes
Breakthrough Detection Time for Dacarbazine (DTIC): > 240 Minutes
Breakthrough Detection Time for Doxorubicin HCL (Adriamycin): > 240 Minutes
Breakthrough Detection Time for Etoposide (Toposar): > 240 Minutes
Breakthrough Detection Time for Fluorouracil (Adrucil): > 240 Minutes
Breakthrough Detection Time for Paclitaxel (Taxol): > 240 Minutes
Breakthrough Detection Time for Thio TEPA: 62.6 Minutes

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.

K190860

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 28, 2022 Taishan Weibang Medical Equipment Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai. 200120 China

Re: K213662

Trade/Device Name: Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: March 11, 2022 Received: March 17, 2022

Dear Boyle Wang:

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 medical devices and radiation-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. Acting 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) K213662

Device Name

Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

Chemotherapy Drug	Concentration	Breakthrough Detection Time in Minutes
Carmustine (BCNU)	3.3 mg/ml (3,300 ppm)	33.5 Minutes
Cisplatin	1.0 mg/ml(1,000 ppm)	> 240 Minutes
Cyclophosphamide (Cytoxan)	20.0 mg/ml(20,000 ppm)	> 240 Minutes
Dacarbazine (DTIC)	10.0 mg/ml(10,000 ppm)	> 240 Minutes
Doxorubicin HCL (Adriamycin)	2.0 mg/ml(2,000 ppm)	> 240 Minutes
Etoposide (Toposar)	20.0 mg/ml(20,000 ppm)	> 240 Minutes
Fluorouracil (Adrucil)	50.0 mg/ml(50,000 ppm)	> 240 Minutes
Paclitaxel (Taxol)	6.0 mg/ml(6,000 ppm)	> 240 Minutes
Thio TEPA	10.0 mg/ml(10,000 ppm)	62.6 Minutes

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 33.5 Minutes Thio-Tepa 10.0 mg/ml 62.6 Minutes

Warning: Please do not use with Carmustine (BCNU) and Thiotepa.

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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510(k) Summary K213662

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1.0 Submitter's Information

Name: Taishan Weibang Medical Equipment Co., Ltd. Address: No.8, Jiangdong Industrial Park, Dajiang Town, Taishan, Jiangmen, Guangdong, China. Contact: Shuhui Zhou Date of Preparation: Mar.28, 2022

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) Patient Examination Gloves Common name: Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

3.0 Classification

Production code: LZA,LZC Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: Ever Growth (Vietnam) Co., Ltd. Device: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy

4

Drugs, Orange Color 510(k) number: K190860

5.0 Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.

6.0 Indication for Use_

A patient examination qlove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs

| Chemotherapy Drug | Concentration | Breakthrough Detection
Time in Minutes |
|-------------------------------|------------------------|-------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 33.5 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 62.6 |

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 33.5 Minutes; Thio Tepa 10.0 mg/ml 62.6 Minutes.

Warning: Please do not use with Carmustine (BCNU) and Thiotepa.

7.0 Technological Characteristic Comparison Table

5

| Item | Subject Device
(K213662) | Predicate Device
(K190860) | Remark |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Product Code | LZA,LZC | LZA,LZC | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use/
Indications for Use | A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | Same |
| Powdered or Powered
free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity,Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results. | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile, a statement of standard ASTM D6978-05 compliance and a summary of the testing results. | Same |
| Dimensions(mm) | Length:
S:≥220;
M/L/XL: ≥230;
Width:
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 | Length:
XS/S/M/L/XL: ≥230;
Width:
XS:70±10;
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10 | Similar
Analysis 1 |
| Thickness(mm) | Finger: ≥0.05; | Finger: ≥0.05; | Same |

Table1-General Comparison

6

	Palm: ≥0.05	Palm: ≥0.05
	Colorant	Blue	White, Orange	Different
Analysis 2
Physical
Properties	Before
Aging	Tensile
Strength	14MPa, min	Tensile Strength	14MPa, min	Same
		Ultimate
Elongation	500% min	Ultimate
Elongation	500% min	Same
	After Aging	Tensile
Strength	14MPa, min	Tensile Strength	14MPa, min	Same
		Ultimate
Elongation	400%min	Ultimate
Elongation	400%min	Same
Freedom from Holes		Be free from holes when
tested in accordance with
ASTMD5151 AQL=2.5		Be free from holes when
tested in accordance with
ASTMD5151 AQL=2.5		Same
Powder Content		0.15-0.19 mg per glove,
Meet the requirements of
ASTM D6124		Meet the requirements of
ASTM D6124		Similar
Analysis 3
Biocompatibility		ISO 10993-10;
Under the conditions of the
study, not an irritant or a
sensitizer.		ISO 10993-10;
Under the conditions of the
study, not an irritant or a
sensitizer		Same
		ISO 10993-5
Under conditions of the
study, device extract is
cytotoxic.		ISO 10993-5
Under conditions of the
study, device extract is not
cytotoxic		Different
Analysis 4
		ISO 10993-11;
Under the
condition of acute
systemic toxicity test,
the test article did not
show acute systemic
toxicity in vivo.		N.A.		/
Chemotherapy Drugs
Tested with Minimum
Breakthrough
Detection Time as		Carmustine (BCNU) 3.3
mg/ml: 33.5 Minutes		Carmustine (BCNU) 3.3
mg/ml:
White:11.8 Minutes;
Orange:31.6Minutes		Similar
Analysis 5
Tested per ASTM D
6978		Cisplatin 1.0 mg/ml: > 240
Minutes		Cisplatin 1.0 mg/ml: >240
Minutes		Same

7

| | Cyclophosphamide
(Cytoxan) 20.0 mg/ml: >
240 Minutes | Cyclophosphamide
(Cytoxan)
20.0 mg/ml: > 240 Minutes | Same |
|--|------------------------------------------------------------|----------------------------------------------------------------------|-----------------------|
| | Dacarbazine (DTIC) 10.0 mg/ml: > 240 Minutes | Dacarbazine (DTIC) 10.0 mg/ml:

240 Minutes | Same |
| | Doxorubicin HCl 2.0 mg/ml:
240 Minutes | Doxorubicin Hydrochloride
2.0
mg/ml: >240 Minutes | Same |
| | Etoposide 20.0 mg/ml: >
240 Minutes | Etoposide (Toposar) 20.0
mg/ml: >240 Minutes | Same |
| | Fluorouracil 50.0 mg/ml: >
240 Minutes | Fluorouracil 50.0 mg/ml: >
240
Minutes | Same |
| | Paclitaxel 6.0 mg/ml: >240
Minutes | Paclitaxel (Taxol) 6.0
mg/ml:
240 Minutes | Same |
| | Thio Tepa 62.6 mg/ml: 15.2
Minutes | Thio-Tepa 10.0 mg/ml:
White:16.9 Minutes;
Orange: 72.5 Minutes | Similar
Analysis 5 |

Analysis 1:

The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

Analysis 2:

The color of the subject device is different with that of the predicate. The subject device was evaluated according to ISO 10993-1 standards, and there were no risks identified.

Analysis 3:

Powder Content of subject device is similar with that of the predicate, because the predicate did not publish the exact results of the powder content. But they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

Analysis 4:

Under conditions of the study, cytotoxicity of the subject device is different with that of the predicate. But under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. So there were no risks identified.

Analysis 5:

8

And Breakthrough detection times of Carmustine (BCNU) and Thio Tepa of subject device are different with those of the predicate. The Chemotherapy Labeling Claims has clearly defined on the labeling. So it does not raise any new safety or performance questions.

8.0 Summary of Non-Clinical Testing

Biocompatibility Testing

The biocompatibility evaluation for Medical Examination Gloves (Tested for Use with Chemotherapy Drugs) was conducted in accordance with the following standards:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.

ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.

Performance Testing (Bench)

Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.

In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in -Medical Gloves.

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ASTM D6319-19, Standard Specification for Nitrile Examination Gloves i for Medical Application.
ASTM D 6978-05 (Reapproved 2019) ,Standard Practice for । Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6319	Physical Dimensions Test	Length(mm):
S:≥220;
M/L/XL:≥230;
Width(mm):
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10
Thickness (mm):
Finger: ≥0.05
Palm: ≥0.05	Length(mm):
≥ 230/Pass;
Width(mm):
S: 85-89 /Pass
M: 94-97/ Pass
L: 100-104/ Pass
XL:110-113/ Pass
Thickness (mm):
Finger: 0.16-0.18/Pass
Palm: 0.11-0.12/Pass
ASTM D5151	Watertightness Test for Detection of Holes	Meet the requirements of ASTM D5151
AQL 2.5	0/125/Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124
2.0mg	0.15-0.19mg/Pass;
ASTM D412	Physical properties	Before Aging Tensile Strength ≥14MPa
Ultimate Elongation ≥500%
After Aging Tensile Strength ≥14MPa
Ultimate Elongation ≥400%	16.5-33.1MPa/Pass;
500-585%/Pass;
14.1-28.3MPa/Pass;
482-555%/Pass;
ISO 10993-5	Cytotoxicity	Non-cytotoxic	Under conditions of the study, device extract is cytotoxic
ISO
10993-11	Acute systemic
toxicity	Non- acute systemic
toxicity	Under conditions of
the study, did not
show acute systemic
toxicity in vivo / Pass
ISO
10993-10	Irritation	Non-irritating	Under the conditions
of the study, not an
irritant/ Pass
ISO
10993-10	Sensitization	Non-sensitizing	Under conditions of
the study, not a
sensitizer./ Pass

Table 2 - Summary of non-clinical performance testing

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9.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K190860.