Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a disposable medical glove and the description focuses on material properties and performance testing, with no mention of AI or ML.

Therapeutic

No
The device is a medical examination glove used to prevent contamination, not to treat a disease or condition.

Diagnostic

No

Explanation: The device is a non-powdered patient examination glove intended to prevent contamination between patient and examiner. There is no mention of it being used to diagnose any disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made of nitrile and other materials, intended for physical examination and protection. There is no mention of software components.

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 patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on a specimen.
Device Description: The description details a physical barrier (a glove) made of nitrile rubber. It doesn't describe any components or processes related to analyzing biological samples.
Performance Studies: The performance studies focus on the physical properties of the glove (dimension, strength, freedom from holes, etc.) and its resistance to chemical permeation. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.

The testing for chemotherapy drugs and Fentanyl citrate permeation relates to the glove's protective function as a barrier, not its use as a diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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. In addition, these gloves were tested respectively 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.

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

LZA, LZC, OPJ, QDO

Device Description

This device, Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is a nitrile non-sterile medical examination glove available in various sizes (from extra-small to extra-large) and packaging configuration. The gloves are non-sterile medical examination gloves, seamless, ambidextrous, five fingered. They are made from proprietary formulations composed of NBR (Nitrile Butadiene Rubber), accelerator, bulking agent, and pigment. In addition, no former release powder or chemical is used in its manufacturing process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

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 following bench testing was conducted for the Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate:

Dimension, Test Method: ASTM D3767, Purpose: Determine the geometrical dimension of gloves, Acceptance Criteria: Length: XS&S ≥ 220 mm; M&L&XL ≥230 mm. Thickness: Palm - 0.05 mm min. Finger - 0.05 mm min. Palm Width: X-small 70 ± 10 mm Small 85 ± 10 mm Medium 95 ± 10 mm Large 110 ± 10 mm X-Large 120 ± 10 mm, Results: Pass
Freedom from holes (Water leak), Test Method: 21 CFR 800.20. & ASTM D5151-19, Purpose: Detect the holes on the gloves., Acceptance Criteria: G-I/AQL 2.5, Results: Pass
Tensile strength (Before aging/After aging), Test Method: ASTM D412-16 & ASTM D573-04, Purpose: Evaluate the tensile (tenson) properties of the gloves. In addition, it also determines the influence of elevated temperature on the physical properties of gloves., Acceptance Criteria: Before Aging: 14 MPa, min. After Aging: 14 MPa, min, Results: Pass
Elongation (Before aging/After aging), Test Method: ASTM D412-16 & ASTM D573-04, Purpose: influence of elevated temperature on the physical properties of gloves., Acceptance Criteria: Before Aging: 500% min. After Aging: 400% min., Results: Pass
Powder Residual, Test Method: ASTM D6124-06, Purpose: Determine the average powder mass found on the gloves, Acceptance Criteria:

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). 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 27, 2024

Ever Growth (Vietnam) Corporation Limited Deng Elizabeth U.S. Agent Long Khanh Industrial Zone, Binh Loc Commune. Long Khanh City, Dong Nai 76461 Vietnam

Re: K234097

Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Natural 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: LZA, LZC, OPJ, QDO Dated: December 1, 2023 Received: December 26, 2023

Dear Deng Elizabeth:

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 (the 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 available 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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

2

Sincerely,

Bifeng Qian -S

Bifeng Qian, M.D, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K234097

Device Name

Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Indications for Use (Describe)

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. In addition, these gloves were tested respectively 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.

No.	Test Chemotherapy Drug and Concentration	Minimum Breakthrough Detection Time (Min.)
1	Bleomycin Sulfate 15.0 mg/ml	> 240
2	Busulfan 6.0 mg/ml	> 240
3	Carboplatin 10.0 mg/ml	> 240
4	Carmustine (BCNU) 3.3 mg/ml	59.4
5	Chloroquine 50.0 mg/ml	> 240
6	Cisplatin 1 mg/ml	> 240
7	Cyclophosphamide 20 mg/ml	> 240
8	Cyclosporin A 100.0 mg/ml	> 240
9	Cytarabine 100.0 mg/ml	> 240
10	Dacarbazine (DTIC), 10.0 mg/ml	> 240
11	Daunorubicin 5.0 mg/ml	> 240
12	Docetaxel 10.0 mg/ml	> 240
13	Doxorubicin Hydrochloride 2.0 mg/ml	> 240
14	Epirubicin 2.0 mg/ml	> 240
15	Etoposide (Toposar) 20.0 mg/ml	> 240
16	Fludarabine 25.0 mg/ml	> 240
17	Fluorouracil 50.0 mg/ml	> 240
18	Gemcitabine 38.0 mg/ml	> 240
19	Idaribicin 1.0 mg/ml	> 240
20	Ifosfamide 50.0 mg/ml	> 240
21	Irinotecan 20.0 mg/ml	> 240
22	Mechlorethamine HCl 1.0 mg/ml	> 240
23	Melphalan 5.0 mg/ml	> 240
24	Methotrexate 25 mg/ml	> 240
25	Mitomycin C 0.5 mg/ml	> 240
26	Mitoxantrone 2.0 mg/ml	> 240
27	Oxaliplatin 2.0 mg/ml	> 240
28	Paclitaxel (Taxol), 6.0 mg/ml	> 240
29	Paraplatin 10 mg/ml	> 240
30	Retrovir 10 mg/ml	> 240
31	Rituximab 10 mg/ml	> 240
32	Thiotepa, 10.0 mg/ml	118.5
33	Topotecan HCl 1.0 mg/ml	> 240
34	Trisonex 1.0 mg/ml	> 240
35	Velcade (Bortezomib) 1.0 mg/ml	> 240
36	Vincristine 1.0 mg/ml	> 240

4

Fentanyl Citrate Injection 100 mcg/2ml

Thiotepa and Carmustine have low permeation times

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

240

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5

0.0 Summary Preparation Date: March 23, 2024

1.0 Submitter:

Submitter's name:

Submitter's address:

Phone number: Fax number: Name of contact person:

2.0 US Agent:

US Representative Name: Company Address:

Telephone Number: Contact Email Address:

3.0 Name of the Device

Proprietary/Trade name:

Common Name:

Classification Name: Device Classification: Regulation Number: Product Code:

4.0 Predicate device

Device Name:

Company name:

510(K) Number:

EVER GROWTH (VIETNAM) CORPORATION LIMITED Long Khanh Industrial Zone, Binh Loc Commune, Long Khanh City, Dong Nai, VN 76461 84-61-3514022 84-61-3514023 Jerry Lin

Elizabeth Deng 5748 Eaglewood Place Rancho Cucamonga, California Rancho Cucamonga, CA 91739 909 4659188 baxianunited48(@yahoo.com

Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Non-powdered Patient Examination Glove Class I 21 CFR 880.6250 LZA, LZC, OPJ, QDO

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested for Use with Chemotherapy Drugs EVER GROWTH (VIETNAM) CORPORATION LIMITED K190736

6

5.0 Device Description:

This device, Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is a nitrile non-sterile medical examination glove available in various sizes (from extra-small to extra-large) and packaging configuration. The gloves are non-sterile medical examination gloves, seamless, ambidextrous, five fingered. They are made from proprietary formulations composed of NBR (Nitrile Butadiene Rubber), accelerator, bulking agent, and pigment. In addition, no former release powder or chemical is used in its manufacturing process.

6.0 Device Indications for use:

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. In addition, these gloves were tested respectively for use with chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by

No.	Test Chemotherapy Drug and Concentration	Minimum Breakthrough Detection Time (Min.)*
1	Bleomycin Sulfate 15.0 mg/ml	> 240
2	Busulfan 6.0 mg/ml	> 240
3	Carboplatin 10.0 mg/ml	> 240
4	Carmustine (BCNU) 3.3 mg/ml	59.4
5	Chloroquine 50.0 mg/ml	> 240
6	Cisplatin 1 mg/ml	> 240
7	Cyclophosphamide 20 mg/ml	> 240
8	Cyclosporin A 100.0 mg/ml	> 240
9	Cytarabine 100.0 mg/ml	> 240
10	Dacarbazine (DTIC), 10.0 mg/ml	> 240
11	Daunorubicin 5.0 mg/ml	> 240
12	Docetaxel 10.0 mg/ml	> 240
13	Doxorubicin Hydrochloride 2.0 mg/ml	> 240
14	Epirubicin 2.0 mg/ml	> 240
15	Etoposide (Toposar), 20.0 mg/ml	> 240
16	Fludarabine 25.0 mg/ml	> 240
17	Fluorouracil 50.0 mg/ml	> 240
18	Gemcitabine 38.0 mg/ml	> 240

7

| No. | Test Chemotherapy Detection Time (Min.)* |
|-----|---------------------- | 19 | Idaribicin 1.0 mg/ml | 20 | Ifosfamide 50.0 mg/ml | 21 | Irinotecan 20.0 mg/ml | 22 | Mechlorethamine HCl 1.0 mg/ml | 23 | Melphalan 5.0 mg/ml | 24 | Methotrexate 25 mg/ml | 25 | Mitomycin C 0.5 mg/ml | 26 | Mitoxantrone 2.0 mg/ml | 27 | Oxaliplatin 2.0 mg/ml | 28 | Paclitaxel (Taxol) 6.0 mg/ml | 29 | Paraplatin 10 mg/ml | 30 | Retrovir 10 mg/ml | 31 | Rituximab 10 mg/ml | 32 | Thiotepa 10.0 mg/ml | 33 | Topotecan HCl 1.0 mg/ml | 34 | Trisonex 1.0 mg/ml | 35 | Velcade (Bortezomib) 1.0 mg/ml | 36 | Vincristine 1.0 mg/ml | | Fentanyl Citrate Test | | Fentanyl Citrate Injection
100 mcg/2ml | >240 Drug and Concentration | Minimum Breakthrough
---------------------|------------------------------------------------|
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| 118.5 |
| > 240 |
| > 240 |
| > 240 |
| > 240 |
| |
|

*The maximum testing time is 240 minutes

Please note that the following drug has an extremely low permeation time:

| No. | Test Chemotherapy Drug and Concentration | Minimum Breakthrough
Detection Time (Min.) |
|-----|------------------------------------------|-----------------------------------------------|
| 4 | Carmustine (BCNU) 3.3 mg/ml | 59.4 |
| 32 | Thiotepa, 10.0 mg/ml | 118.5 |

8

7.0 Comparison of device technological characteristics:

| 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, Natural
Blue Color, Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate	same except
color
510(K) No.	K190736	K234097	n/a
Product Owner	Ever Growth (Vietnam)
Corporation Limited	Ever Growth (Vietnam)
Corporation Limited	same
Product Code	LZA & LZC	LZA & LZC, OPJ, QDO	same
Regulation	21 CFR 880.6250	21 CFR 880.6250	same
Class	I	I	same
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 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 and
Fentanyl citrate in accordance
with ASTM D6978-05 Standard
Practice for Assessment of
Medical gloves to Permeation
by Chemotherapy Drugs.	similar
Power free	Yes	Yes	same
Size	XS/S/M/L/XL	XS/S/M/L/XL	same
Over-The-
Counter Use	Yes (21 CFR 801 Subpart C)	Yes (21 CFR 801 Subpart C)	same
Single Use	YES	YES	same
Non-Sterile	YES	YES	same
Dimensions-
Length	Complies with ASTM D6319-10
≥ 230 mm	Complies with ASTM D6319-19
XS&S ≥ 220 mm;
M&L&XL ≥ 230 mm	similar
Dimensions -
Palm Width	Complies with ASTM D6319-10
XS: 70 ± 10 mm;
S: 80 ± 10 mm;
M: 95 ± 10 mm;
L: 110 ± 10 mm;
XL: 120 ± 10 mm	Complies with ASTM D6319-19
XS: 70 ± 10 mm;
S: 80 ± 10 mm;
M: 95 ± 10 mm;
L: 110 ± 10 mm;
XL: 120 ± 10 mm	same
Dimensions -
Thickness	Complies with ASTM D6319-10
Palm ≥0.05 mm;
Finger ≥0.05 mm	Complies with ASTM D6319-19
Palm ≥0.05 mm;
Finger ≥0.05 mm	same

9

| Device

Characteristic	Predicate Device
Physical
Properties	Complies with ASTM D6319-
10
Tensile Strength
Before aging≥14MPa
After aging ≥14MPa	Complies with ASTM D6319-
19
Tensile Strength
Before aging≥14MPa
After aging ≥14MPa	same
	Complies with ASTM D6319-
10
Elongation:
Before Aging: 500% min.
After Aging: 400% min.	Complies with ASTM D6319-
19
Elongation:
Before Aging: 500% min.
After Aging: 400% min.	same
Residual
powder	Complies with ASTM D6319-
10
240 2 Busulfan 6.0 mg/ml > 240 3 Carboplatin 10.0
mg/ml > 240 4 Carmustine (BCNU),
3.3 mg/ml 59.4 5 Chloroquine 50.0
mg/ml > 240 6 Cisplatin 1.0 mg/ml > 240 7 Cyclophosphamide
20 mg/ml > 240 8 Cyclosporin A 100.0
mg/ml > 240 9 Cytarabine 100.0
mg/ml > 240 10 Dacarbazine (DTIC),
10.0 mg/ml > 240 11 Daunorubicin 5.0
mg/ml > 240 12 Docetaxel 10.0
mg/ml > 240		no. Test Chemotherapy
Drug and
Concentration Minimum
Breakthro
ugh
Detection
Time
(Min.) 1 Bleomycin Sulfate
15.0 mg/ml > 240 2 Busulfan 6.0 mg/ml > 240 3 Carboplatin 10.0
mg/ml > 240 4 Carmustine (BCNU),
3.3 mg/ml 59.4 5 Chloroquine 50.0
mg/ml > 240 6 Cisplatin 1.0 mg/ml > 240 7 Cyclophosphamide
20 mg/ml > 240 8 Cyclosporin A 100.0
mg/ml > 240 9 Cytarabine 100.0
mg/ml > 240 10 Dacarbazine (DTIC),
10.0 mg/ml > 240 11 Daunorubicin 5.0
mg/ml > 240 12 Docetaxel 10.0
mg/ml > 240		similar

10

| 13 | Doxorubicin
Hydrochloride, 2.0
mg/ml | > 240 | 13 | Doxorubicin
Hydrochloride, 2.0
mg/ml | > 240 | |
|----|----------------------------------------------|-------|----|----------------------------------------------|-------|--|
| 14 | Epirubicin 2.0 mg/ml | > 240 | 14 | Epirubicin 2.0 mg/ml | > 240 | |
| 15 | Etoposide (Toposar),
20.0 mg/ml | > 240 | 15 | Etoposide (Toposar),
20.0 mg/ml | > 240 | |
| 16 | Fludarabine 25.0
mg/ml | > 240 | 16 | Fludarabine 25.0
mg/ml | > 240 | |
| 17 | Fluorouracil, 50.0
mg/ml | > 240 | 17 | Fluorouracil, 50.0
mg/ml | > 240 | |
| 18 | Gemcitabine 38.0
mg/ml | > 240 | 18 | Gemcitabine 38.0
mg/ml | > 240 | |
| 19 | Idaribicin 1.0 mg/ml | > 240 | 19 | Idaribicin 1.0 mg/ml | > 240 | |
| 20 | Ifosfamide 50.0
mg/ml | > 240 | 20 | Ifosfamide 50.0
mg/ml | > 240 | |
| 21 | Irinotecan 20.0
mg/ml | > 240 | 21 | Irinotecan 20.0
mg/ml | > 240 | |
| 22 | Mechlorethamine
HCl 1.0 mg/ml | > 240 | 22 | Mechlorethamine
HCl 1.0 mg/ml | > 240 | |
| 23 | Melphalan 5.0 mg/ml | > 240 | 23 | Melphalan 5.0 mg/ml | > 240 | |
| 24 | Methotrexate 25
mg/ml | > 240 | 24 | Methotrexate 25
mg/ml | > 240 | |
| 25 | Mitomycin C 0.5
mg/ml | > 240 | 25 | Mitomycin C 0.5
mg/ml | > 240 | |
| 26 | Mitoxantrone 2.0
mg/ml | > 240 | 26 | Mitoxantrone 2.0
mg/ml | > 240 | |
| 27 | Oxaliplatin 2.0 mg/ml | > 240 | 27 | Oxaliplatin 2.0 mg/ml | > 240 | |
| 28 | Paclitaxel (Taxol),
6.0 mg/ml | > 240 | 28 | Paclitaxel (Taxol),
6.0 mg/ml | > 240 | |
| 29 | Paraplatin 10 mg/ml | > 240 | 29 | Paraplatin 10 mg/ml | > 240 | |
| 30 | Retrovir 10 mg/ml | > 240 | 30 | Retrovir 10 mg/ml | > 240 | |
| 31 | Rituximab 10 mg/ml | > 240 | 31 | Rituximab 10 mg/ml | > 240 | |
| 32 | Thiotepa, 10.0 mg/ml | 118.5 | 32 | Thiotepa, 10.0 mg/ml | 118.5 | |
| 33 | Topotecan HCl 1.0
mg/ml | > 240 | 33 | Topotecan HCl 1.0
mg/ml | > 240 | |
| 34 | Trisonex 1.0 mg/ml | > 240 | 34 | Trisonex 1.0 mg/ml | > 240 | |
| 35 | Velcade
(Bortezomib) 1.0
mg/ml | > 240 | 35 | Velcade
(Bortezomib) 1.0
mg/ml | > 240 | |
| 36 | Vincristine 1.0 mg/ml | > 240 | 36 | Vincristine 1.0 mg/ml | > 240 | |
| 37 | Fentanyl Citrate
Injection
100 mcg/2ml | n/a | 37 | Fentanyl Citrate
Injection
100 mcg/2ml | >240 | |

11

8.0 Assessment of Non-Clinical Performance Data:

The following bench testing was conducted for the Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.:

Test	Test Method	Purpose
Dimension	ASTM D3767	Determine the
geometrical
dimension of gloves	Length: XS&S ≥ 220 mm; M&L&XL ≥230 mm.
Thickness:
Palm - 0.05 mm min.
Finger - 0.05 mm min.
Palm Width:
X-small 70 ± 10 mm
Small 85 ± 10 mm
Medium 95 ± 10 mm
Large 110 ± 10 mm
X-Large 120 ± 10 mm	Pass
Freedom from
holes (Water leak)	21 CFR 800.20.
&
ASTM D5151-19	Detect the holes on
the gloves.	G-I/AQL 2.5	Pass
Tensile strength
(Before
aging/After aging)	ASTM D412-16
& ASTM D573-
04	Evaluate the tensile
(tenson) properties of
the gloves. In
addition, it also
determines the	Before Aging: 14 MPa,
min.
After Aging: 14 MPa,
min	Pass
Elongation (Before
aging/After aging)	ASTM D412-16
& ASTM D573-
04	influence of elevated
temperature on the
physical properties of
gloves.	Before Aging: 500%
min.
After Aging: 400% min.	Pass
Powder Residual	ASTM D6124-06	Determine the
average powder mass
found on the gloves