Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The device, a patient examination glove, is intended as a barrier to prevent contamination, not to treat or cure a disease or medical condition.

Diagnostic

No

Explanation: The device is a "patient examination glove" intended to provide a barrier between a patient and examiner. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of nitrile, not software. The description focuses on material properties and barrier protection.

IVD (In Vitro Diagnostic)

No, 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 purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This describes a barrier device used during patient examination, not a device used to test samples outside of the body to diagnose a condition.
Device Description: The description focuses on the physical properties of the glove (material, color, powder-free, non-sterile) and its function as a barrier.
Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information about a patient's health status, diagnose diseases, or monitor treatment. This glove does not perform any such function.
Testing: While the glove is tested for resistance to chemotherapy drugs and fentanyl, this testing is related to its barrier function and safety for the user, not for diagnosing or monitoring a patient's condition.

In summary, this device is a medical device (specifically, a patient examination glove), but it falls under a different regulatory category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 and fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.

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

LZC, LZA, QDO

Device Description

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or Fingers

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)

The device underwent non-clinical testing for various characteristics including:

Dimension: Conforms to ASTM D6319-10 (Reapproved 2015) for length (short cuff ≥230mm, long cuff ≥300mm), width (X Small 70±10mm, Small 80±10mm, Medium 95±10mm, Large 110±10mm, X large 120±10mm), and thickness (Finger tip ≥0.05mm, Palm ≥0.05mm, Cuff ≥0.05mm).
Physical Properties: Conforms to ASTM D6319-10 (Reapproved 2015) for Tensile strength (Before Aging ≥14MPa, After Aging ≥14MPa) and Elongated rate (Before Aging ≥500%, After Aging ≥400%).
Freedom from pinholes: In accordance with 21 CFR 800.20, ASTM D6319-10 (Reapproved 2015), and ASTM D5151-06 (Reapproved 2015), G-1, AQL 2.5. Passed Standard Acceptance Criteria.
Powder Residual: Conforms to ASTM D6319-10 (Reapproved 2015) and D6124-06 (Reaffirmation 2011), with a result of 240 minutes. Carmustine (BCNU) had a breakthrough time of 6.2 minutes, and Thiotepa had a breakthrough time of 13.6 minutes. Fentanyl Citrate Injection (100mcg/2mL) showed no breakthrough detected up to 240 minutes.

Key results: The nonclinical tests demonstrated that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K190403.

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

Minimum Breakthrough Detection Time (Min.) for various chemotherapy drugs and Fentanyl Citrate Injection.

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.

K190403

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 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.

June 4, 2020

Ever Global (Vietnam) Enterprise Corp % Elizabeth Deng U.S. Representative Elizabeth Deng 5748 Eaglewood Place Ranch Cucamonga, California 91730

Re: K193555

Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, 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: LZC, LZA, QDO Dated: April 29, 2020 Received: May 5, 2020

Dear Elizabeth Deng:

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.

CAPT Elizabeth Claverie, M.S. 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

Ever Global (Vietnam) Enterprise Corporation

Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam

| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | | | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--|---------------------------------------------------------------------------------------------|
| Indications for Use | | | | |
| 510(k) Number (if known) | K193555 | | | |
| Device Name | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate | | | |
| Indications for Use (Describe) | 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 and fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of
Resistance of Medical gloves to Permeation by Chemotherapy Drugs. | | | |
| Test Chemotherapy Drug | Concentration (mg/ml) | Minimum Breakthrough Detection Time (Min.) | | |
| 01 Arsenic Trioxide | 1.0 | > 240 | | |
| 02 Azacitidine (Vidaza) | 25.0 | > 240 | | |
| 03 Bendamustine HCl | 5.0 | > 240 | | |
| 04 Bleomycin Sulfate | 15.0 | > 240 | | |
| 05 Bortezomib (Velcade) | 1.0 | > 240 | | |
| 06 Busulfan | 6.0 | > 240 | | |
| 07 Carboplatin | 10.0 | > 240 | | |
| 08 Carfilzomib | 2.0 | > 240 | | |
| 09 Carmustine (BCNU) | 3.3 | 6.2 | | |
| 10 Cetuximab (Erbitux) | 2.0 | > 240 | | |
| 11 Chloroquine | 50.0 | > 240 | | |
| 12 Cisplatin | 1.0 | > 240 | | |
| 13 Cladribine | 1.0 | > 240 | | |
| 14 Cyclophosphamide | 20.0 | > 240 | | |
| 15 Cyclosporine A | 100.0 | > 240 | | |
| 16 Cytarabine mg/ml) | 100.0 | > 240 | | |
| 17 Cytovene (Ganciclovir) | 10.0 | > 240 | | |
| 18 Dacarbazine | 10.0 | > 240 | | |
| 19 Daunorubicin | 5.0 | > 240 | | |
| 20 Decitabine | 5.0 | > 240 | | |
| 21 Docetaxel | 10.0 | > 240 | | |
| 22 Doxorubicin Hydrochloride | 2.0 | > 240 | | |
| 23 Epirubicin (Ellence) | 2.0 | > 240 | | |
| 24 Etoposide | 20.0 | > 240 | | |
| 25 Fludarabine | 25.0 | > 240 | | |
| 26 Fluorouracil | 50.0 | > 240 | | |
| 27 Fulvestrant | 50.0 | > 240 | | |
| 28 Gemcitabine | 38.0 | > 240 | | |
| 29 Idarubicin | 1.0 | > 240 | | |
| 30 Ifosfamide | 50.0 | > 240 | | |
| 31 Irinotecan | 20.0 | > 240 | | |
| 32 Mechlorethamine HCl | 1.0 | > 240 | | |
| 33 Melphalan | 5.0 | > 240 | | |
| 34 Methotrexate | 25.0 | > 240 | | |
| 35 Mesna | 100.0 | > 240 | | |
| 36 Mitomycin C | 0.5 | > 240 | | |
| 37 Mitoxantrone | 2.0 | > 240 | | |
| FORM FDA 3881 (7/17) | Page 1 of 2 | PSC Publishing Services (301) 443-6740 | | |

3

Ever Global (Vietnam) Enterprise Corporation

Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam

38 Oxaliplatin	5.0	> 240
39 Paclitaxel	6.0	> 240
40 Paraplatin	10.0	> 240
41 Pemetrexed	25.0	> 240
42 Pertuzumab	30.0	> 240
43 Raltitrexed	0.5	> 240
44 Retrovir	10.0	> 240
45 Rituximab	10.0	> 240
46 Temsirolimus	25.0	> 240
47 Thiotepa	10.0	13.6
48 Topotecan HCl	1.0	> 240
49 Trastuzumab	21.0	> 240
50 Triclosan	2.0	> 240
51 Trisenox	1.0	> 240
52 Vinblastine	1.0	> 240
53 Vincristine Sulfate	1.0	> 240
54 Vinorelbine	10.0	> 240
55 Zoledronic Acid	0.8	> 240
Warning: do not use with Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
Carmustine (BCNU)	3.3 mg/ml	6.2 minutes
Thiotepa	10.0 mg/ml	13.6 minutes
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate
Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Type of Use (Select one or both, as applicable)
Image: Checkbox	Over-The-Counter Use (21 CFR 801 Subpart C)
Image: Unchecked checkbox	Prescription Use (Part 21 CFR 801 Subpart D)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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4

510(K) SUMMARY

K193555

1.0 Submitter:

Submitter's name :	Ever Global (Vietnam) Enterprise Corp.
Submitter's address :	Long Thanh Industrial Zone
Taman Village Dong Nai Province, VN 810000
Phone number :	84-61-3514022
Fax number :	84 -61-3514023
Name of contact person:	Jerry Lin
Summary Preparation Date:	May 27th,2020
2.0 US Agent:
US representative name:	Elizabeth Deng
Company address:	5748 Eaglewood Place
Rancho Cuamonga, California
Rancho Cucamonga, CA 91739
Telephone number:	909 4659188
Contact email:	Baxianunited48@Yahoo.Com
3.0 Name of the Device
Proprietary/Trade name:	Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For
Use With Chemotherapy Drugs and Fentanyl Citrate
Common Name:	Nitrile Examination Gloves
Classification Name:	Patient Examination Glove
Device Classification:	Class I
Regulation Number:	21 CFR 880.6250
Product Code:	LZA, LZC, QDO
4.0 Predicate device
Device Name:	Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For
Use With Chemotherapy Drugs
Company name:	Ever Global (Vietnam) Enterprise Corp.
510(K) Number:	K190403

5.0 Device Description:

"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

6.0 Indication for use:

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate

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 resistance of medical gloves to permeation by chemotherapy drugs.

5

| No. | Test Chemotherapy Drug and
Concentration | Minimum Detection Time (Min.) |
|-----|------------------------- | 1 | Arsenic Trioxide (1.0 mg/ml) | 2 | Azacitidine (Vidaza) (25.0 mg/ml) | 3 | Bendamustine HCl (5.0 mg/ml) | 4 | Bleomycin Sulfate (15.0 mg/ml) | 5 | Bortezomib (Velcade) (1.0 mg/ml) | 6 | Busulfan (6.0 mg/ml) | 7 | Carboplatin (10.0 mg/ml) | 8 | Carfilzomib (2.0 mg/ml) | 9 | Carmustine (BCNU), (3.3 mg/ml) | 10 | Cetuximab (Erbitux) (2.0 mg/ml) | 11 | Chloroquine (50.0 mg/ml) | 12 | Cisplatin (1.0 mg/ml) | 13 | Cladribine (1.0 mg/ml) | 14 | Cyclophosphamide (20.0 mg/ml) | 15 | Cyclosporine A (100.0 mg/ml) | 16 | Cytarabine (100.0 mg/ml) | 17 | Cytovene (Ganciclovir) (10.0 mg/ml) | 18 | Dacarbazine (10.0 mg/ml) | 19 | Daunorubicin (5.0 mg/ml) | 20 | Decitabine (5.0 mg/ml) | 21 | Docetaxel (10.0 mg/ml) | 22 | Doxorubicin Hydrochloride | 23 | Epirubicin (Ellence) (2.0 mg/ml) | 24 | Etoposide (20.0 mg/ml) | 25 | Fludarabine (25.0 mg/ml) | 26 | Fluorouracil (50.0 mg/ml) | 27 | Fulvestrant (50.0 mg/ml) | 28 | Gemcitabine (38.0 mg/ml) | 29 | Idarubicin (1.0 mg/ml) | 30 | Ifosfamide (50.0 mg/ml) | 31 | Irinotecan (20.0 mg/ml) | 32 | Mechlorethamine HCl (1.0 mg/ml) | 33 | Melphalan (5.0 mg/ml) | 34 | Methotrexate (25 mg/ml) | 35 | Mesna (100 mg/ml) | 36 | Mitomycin C (0.5 mg/ml) | 37 | Mitoxantrone (2.0 mg/ml) | 38 | Oxaliplatin (5.0 mg/ml) | 39 | Paclitaxel (6.0mg/ml) | 40 | Paraplatin (10.0 mg/ml) | 41 | Pemetrexed (25.0 mg/ml) | 42 | Pertuzumab (30.0 mg/ml) | 43 | Raltitrexed (0.5 mg/ml) | 44 | Retrovir (10.0 mg/ml) | 45 | Rituximab (10.0 mg/ml) | 46 | Temsirolimus (25.0 mg/ml) | 47 | Thiotepa (10.0 mg/ml) | 48 | Topotecan HCl (1.0 mg/ml) | 49 | Trastuzumab (21.0 mg/ml) | 50 | Triclosan (2.0 mg/ml) | 51 | Trisenox (1.0 mg/ml) | 52 | Vinblastine (1.0 mg/ml) | 53 | Vincristine Sulfate (1.0 mg/ml) | 54 | Vinorelbine (10.0 mg/ml) | 55 | Zoledronic Acid (0.8 mg/ml) Breakthrough
--------------------|-----------------------------------------------|
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| 6.2 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
(2.0 mg/ml) | > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| 13.6 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |

Table 1 Tested for use with 55 chemotherapy drugs.

6

Warning: do not use with Carmustine and Thiotepa.

The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:

Carmustine (BCNU), 3.3 mg/ml	6.2 minutes
Thiotepa, 10.0 mg/ml	13.6 minutes

Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected for up to 240 minutes.

7

7.0 Comparison of Technological characteristics between the predicate and subject devices:

Device Characteristic	Predicate Device	Subject Device	Comparison
Product name	Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs	Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate	similar
510(K) No.	K190403	K193555	N/A
Product Owner	Ever Global (Vietnam) Enterprise Corporation	Ever Global (Vietnam) Enterprise Corporation	same
Product Code	LZA, LZC	LZA, LZC, QDO	similar
Regulation	21 CFR 880.6250	21 CFR 880.6250	same
Class	I	I	same
Intended Use	The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger 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.	The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs And Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.	similar
Powder free	Yes	Yes	same
Size	Small/ Medium/Large/X Large	X Small/ Small/Medium/Large/X Large	X Small is additional.
Single Use	YES	YES	same
Non-Sterile	No	No	same
Dimensions-Length	Complies with ASTM D6319-10 230 mm min.	Short cuff ≥230mm
Long cuff ≥300mm	Long cuff is additional.
Dimensions - Palm Width	Complies with ASTM D6319-10	Complies with ASTM D6319-10	Similar.
X Small is additional.
	Small
Medium
Large	X Small 70±10
Small 80±10
Medium 95 ±10
Large 110±10

Table 2 Comparison of Technological Characteristics

8

| Dimensions - Thickness | | Complies with ASTM D6319-10
Palm 0.05mm min.
Finger 0.05 mm min.
Cuff 0.05 mm min | Complies with ASTM D6319-10
Palm 0.05mm min.
Finger 0.05 mm min.
Cuff 0.05 mm min | same | |
|--------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------|
| Physical
Properties | | Tensile Strength:
Before Aging 14 MPa, min.
After Aging 14 MPa, min.
Elongation:
Before Aging 500% min.
After Aging 400% min. | Tensile Strength:
Before Aging 14 MPa, min.
After Aging 14 MPa, min.
Elongation:
Before Aging 500% min.
After Aging 400% min. | same | |
| Residual
powder | | Complies with ASTM D6319-10
240 | | Different |
| Azacitidine (Vidaza) (25.0 mg/ml) | | - | > 240 | | Different |
| Bendamustine HCI (5.0 mg/ml) | | - | > 240 | | Different |
| | Bleomycin Sulfate (15.0 mg/ml) | - | > 240 | | Different |
| | Bortezomib (Velcade) (1.0 mg/ml) | - | > 240 | | Different |
| Busulfan (6.0 mg/ml) | | - | > 240 | | Different |
| Carboplatin (10.0 mg/ml) | | - | > 240 | | Different |
| Carfilzomib (2.0 mg/ml) | | - | > 240 | | Different |
| Carmustine (BCNU), (3.3 mg/ml) | | 6.2 | 21.5 | 37.5 | Similar |
| Cetuximab (Erbitux) (2.0 mg/ml) | | - | > 240 | | Different |
| Chloroquine (50.0 mg/ml) | | - | > 240 | | Different |
| | Cisplatin (1.0 mg/ml) | > 240 | > 240 | | Same |
| | Cladribine (1.0 mg/ml) | - | > 240 | | Different |
| | Cyclophosphamide (20.0 mg/ml) | > 240 | > 240 | | Same |
| | Cyclosporin A (100.0 mg/ml) | - | > 240 | | Different |
| | Cytarabine (100.0 mg/ml) | - | > 240 | | Different |
| Dacarbazine (DTIC), (10.0 mg/ml) | > 240 | > 240 | Same | | |
| Daunorubicin (5.0 mg/ml) | - | > 240 | Different | | |
| Decitabine (5.0 mg/ml) | - | > 240 | Different | | |
| Docetaxel (10.0 mg/ml) | - | > 240 | Different | | |
| Doxorubicin Hydrochloride (2.0mg/ml) | > 240 | > 240 | Same | | |
| Epirubicin (Ellence) (2.0 mg/ml) | - | > 240 | Different | | |
| Etoposide, (20.0 mg/ml) | > 240 | > 240 | Same | | |
| Fludarabine (25.0 mg/ml) | - | > 240 | Different | | |
| Fluorouracil, (50.0 mg/ml) | > 240 | > 240 | Same | | |
| Fulvestrant (50.0 mg/ml) | - | > 240 | Different | | |
| Gemcitabine (38.0 mg/ml) | - | > 240 | Different | | |
| Idaribicin (1.0 mg/ml) | - | > 240 | Different | | |
| Ifosfamide (50.0 mg/ml) | - | > 240 | Different | | |
| Irinotecan (20.0 mg/ml) | - | > 240 | Different | | |
| Mechlorethamine HCl (1.0 mg/ml) | - | > 240 | Different | | |
| Melphalan (5.0 mg/ml) | - | > 240 | Different | | |
| Methotrexate (25 mg/ml) | - | > 240 | Different | | |
| Mesna (100 mg/ml) | - | > 240 | Different | | |
| Mitomycin C (0.5 mg/ml) | - | > 240 | Different | | |
| Mitoxantrone (2.0 mg/ml) | - | > 240 | Different | | |
| Oxaliplatin (5.0 mg/ml) | - | > 240 | Different | | |
| Paclitaxel (Taxol), (6.0 mg/ml) | > 240 | > 240 | Same | | |
| Paraplatin (10.0 mg/ml) | - | > 240 | Different | | |
| Pemetrexed (25.0 mg/ml) | - | > 240 | Different | | |
| Pertuzumab (30.0 mg/ml) | - | > 240 | Different | | |
| Raltitrexed (0.5 mg/ml) | - | > 240 | Different | | |
| Retrovir (10.0 mg/ml) | - | > 240 | Different | | |
| Rituximab (10.0 mg/ml) | - | > 240 | Different | | |
| Temsirolimus (25.0 mg/ml) | - | > 240 | Different | | |
| Thiotepa (10.0 mg/ml) | 38.8 | 23.1 | 13.6 | Similar | |
| Topotecan HCl (1.0 mg/ml) | - | > 240 | Different | | |
| Trastuzumab (21.0 mg/ml) | - | > 240 | Different | | |
| Triclosan (2.0 mg/ml) | - | > 240 | Different | | |
| Trisenox (1.0 mg/ml) | - | > 240 | Different | | |
| Vinblastine (1.0 mg/ml) | - | > 240 | Different | | |

9

10

Vincristine Sulfate (1.0 mg/ml)	-	> 240	Different
Vinorelbine (10.0 mg/ml)	-	> 240	Different
Zoledronic Acid (0.8 mg/ml)	-	> 240	Different
Fentanyl Permeation Resistance
Fentanyl Citrate Injection, (100
mcg/2ml)	-	> 240	Different

8.0 Summary of Non-clinical testing results:

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate is summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Standard
Dimension	ASTM standard D 6319-10(Reapproved 2015)
	Length
Short cuff
≥230mm
Long cuff
≥300mm
	Width
X Small
$70 \pm 10 mm$
Small
$80 \pm 10 mm$
Medium
$95 \pm 10 mm$
Large
$110 \pm 10 mm$
X large
$120 \pm 10 mm$
	Thickness
Finger tip
≥0.05mm
Palm
≥0.05mm
Cuff
≥0.05mm
Physical
Properties	ASTM standard D 6319-10(Reapproved 2015)
Tensile strength (Before aging)
≥14MPa
Tensile strength (After aging)
≥14MPa
Elongated rate (Before aging)
≥500%
Elongated rate (After aging)
≥400%
Freedom from
pinholes	21 CFR 800.20
ASTM standard D 6319-10(Reapproved 2015)
Test method in accordance with ASTM D5151-
06(Reapproved 2015)
Passed Standard Acceptance Criteria
Powder Residual	ASTM standard D6319-10 (Reapproved 2015)
Test method in accordance with D6124-
06(Reaffirmation 2011)