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 the glove, with no mention of AI or ML.

Therapeutic

No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy or treatment.

Diagnostic

No.
The device is a patient examination glove, which is a barrier device for contamination prevention, not a tool for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made of nitrile, a synthetic rubber, and describes its physical properties and testing related to material performance.

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 clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier device used during patient examination.
Device Description: The description details a physical glove made of nitrile.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis on a specimen.
Testing: While the gloves are tested for resistance to chemotherapy drugs and fentanyl, this testing relates to the glove's barrier properties and safety for the user, not to the diagnosis or analysis of a patient's condition.

Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not an in vitro diagnostic device.

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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Chemotherapy Drug	Breakthrough Detection Time in Minutes
*Carmustine (BCNU)	21.2
Cisplatin	> 240
Cyclophosphamide (Cytoxan)	> 240
Dacarbazine	> 240
Doxorubicin Hydrochloride	> 240
Etoposide	> 240
Fluorouracil	> 240
Ifosfamide	> 240
Methotraxate	> 240
Mitomycin C	> 240
Mitoxantrone	> 240
Paclitaxel	> 240
*Thiotepa	34.6
Vincristine Sulfate	> 240

WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 21.1 minutes and Thiotepa: 34.6. Do not use with Carmustine and Thiotepa.

Fentanyl Resistance	Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection	No breakthrough up to 240 minutes

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

LZA, LZC, ODO

Device Description

Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

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 performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.

Physical Properties

Test Method: ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension)
Purpose of Testing: To evaluate the tensile (tension) properties of glove.
Acceptance Criteria:
- Tensile strength: Min 14.0 MPa (Subject device result: Min 14.0 MPa, Pass)
- Ultimate elongation: Min 500% (Subject device result: Min 400%, Pass)

Dimension

Test Method: ASTM D3767 Standard Practice for Rubber-Measurement of Dimensions
Purpose of Testing: To measure the length, width and thickness of glove
Acceptance Criteria:
- Length (all sizes): Min 240 mm (Pass)
- Width: XS: = 110 (Pass)
- Thickness (all sizes): Finger: Min 0.05 mm; Palm: Min 0.05 mm; Cuff: Min 0.05 mm (Pass)

Watertight

Test Method: ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
Purpose of Testing: To detect holes that leak water and thereby compromise the usefulness of the glove.
Acceptance Criteria: Sample size: 500 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10, Found 2 (Pass)

Residual Powder

Test Method: ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
Purpose of Testing: To determine the amount of residual powder and non-powder solids found on gloves.
Acceptance Criteria: Less than 2 mg per glove (Pass)

Biocompatibility

Primary Skin Irritation:
- Standard: ISO 10993-10:2010 (E) & Consumer Product Safety Commission Title 16, Chapter II, Part 1500
- Result: Passes (Not a primary skin irritant), Primary Irritation Index (PII) was "0".
Dermal Sensitization:
- Standard: ISO 10993-10: 2010 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3 (c) (4)
- Result: Passes (Not a contact sensitizer).
Cytotoxicity:
- Method: MEM Elution, ISO 10993-5: 2009 (E)
- Result: Not Cytotoxic (for predicate). For subject device, Acute systemic toxicity testing performed to demonstrate safety.
Acute Systemic Toxicity:
- Standard: ISO 10993-11:2017 (E)
- Result: Concluded that the product did not induce any systemic toxicity.

Chemotherapy Drugs Permeation Test (per ASTM D6978)

Carmustine (BCNU) (3.3mg/ml): 21.1 minutes
Cisplatin (1.0mg/ml): >240 minutes
Cyclophosphamide (Cytoxan) (20.0mg/ml): >240 minutes
Dacarbazine (10.0mg/ml): >240 minutes
Doxorubicin Hydrochloride (2.0mg/ml): >240 minutes
Etoposide (Toposar) (20.0mg/ml): >240 minutes
Fluorouracil (50.0mg/ml): >240 minutes
Ifosfamide (50.0mg/ml): >240 minutes
Methotrexate (25.0mg/ml): >240 minutes
Mitoxantrone (2.0mg/ml): >240 minutes
Mitomycin C (0.5mg/ml): >240 minutes
Paclitaxel (Taxol) (6.0mg/ml): >240 minutes
*Thiotepa (10.0mg/ml): 34.6 minutes
Vincristine Sulfate (1.0mg/ml): >240 minutes

*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 21.1 minutes and Thiotepa: 34.6. Do not use with Carmustine and Thiotepa.

Fentanyl Resistant (per ASTM D6978)

Fentanyl Citrate Injection (100mcg/2ml): No breakthrough up to 240 minutes

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K183287

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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 4, 2022

WRP Asia Pacific SDN BHD % Saravanan Ramasamy HEAD of QARA Wrp Usa Inc 3700 Massillon Road. Suite 340 Uniontown, Ohio 44685

Re: K210330

Trade/Device Name: Dermagrip Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: February 8, 2022 Received: February 14, 2022

Dear Saravanan Ramasamy:

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.

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

1

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,

Clarence W. Murray, III, PhD 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) K210330

Device Name

DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVE, NON STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL RESISTANCE

Indications for Use (Describe)

A 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. These gloves were tested for use with chemotherapy drugs and Fentany] Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Chemotherapy Drug	Breakthrough Detection Time in Minutes
*Carmustine (BCNU)	21.2
Cisplatin	> 240
Cyclophosphamide (Cytoxan)	> 240
Dacarbazine	> 240
Doxorubicin Hydrochloride	> 240
Etoposide	> 240
Fluorouracil	> 240
Ifosfamide	> 240
Methotraxate	> 240
Mitomycin C	> 240
Mitoxantrone	> 240
Paclitaxel	> 240
*Thiotepa	34.6
Vincristine Sulfate	> 240

WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 21.1 minutes and Thiotepa: 34.6. Do not use with Carmustine and Thiotepa.

Fentanyl Resistance	Breakthrough Detection Time in Minutes
Fentanyl Citrate Injection	No breakthrough up to 240 minutes

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

☐ Prescription Use (Part 21 CFR 801 Subpart D)	❌ Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------

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3

1.0 Submitter:

Name:	Saravanan Ramasamy
Address:	WRP Asia Pacific Sdn Bhd
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,
43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Phone No.:	+60 3 8706 1486
Fax No.:	+60 3 8706 1485

Date of Summary Prepared: 3 March 2022

2.0 Identification of the subject device:

: Dermagrip Powder Free Black Nitrile Patient Examination Trade Name Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance Common Name : Patient Examination Gloves Classification Name : Patient Examination Gloves Device Classification : 1 Regulation Number : 21 CFR 880.6250 Product Code

3.0 Predicate Device:

K183287

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

Company: Kossan International Sdn. Bhd.

4.0 Description of The Device:

Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

5.0 Indication for use:

Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance is a disposable device made of synthetic rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device has also been tested for use with fentanyl citrate.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

4

Chemotherapy Drug Permeation

The following chemicals have been tested for the glove.

| Chemotherapy Drug | Concentration | Breakthrough Detection
Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| *Carmustine (BCNU) | 3.3mg/ml | 21.2 |
| Cisplatin | 1.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| *Thiotepa | 10.0mg/ml | 34.6 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
| Methotrexate | 25.0mg/ml | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 |

*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 21.1 minutes and Thiotepa: 34.6. Do not use with Carmustine and Thiotepa.

| Fentanyl Resistant | Concentration | Breakthrough Detection
Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240
minutes |

6.0 Summary of the Technological Characteristics of the Device:

Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.

5

Table 1
		DEVICE PERFORMANCE
CHARACTERISTICS	STANDARDS	PREDICATE	SUBJECT DEVICE	COMPARISON
ANALYSIS
		BLUE	DERMAGRIP POWDER FREE BLACK
NITRILE PATIENT EXAMINATION
GLOVE, NON-STERILE, TESTED FOR
USE WITH CHEMOTHERAPY DRUGS
AND FENTANYL RESISTANCE
510(k) Number	-	K183287	K210330
Manufacturer(s)	-	Kossan International Sdn. Bhd.	WRP Asia Pacific	Same
Material	ASTM D6319	Nitrile	Nitrile	Same
Color	-	Blue	Black	Same
Texture	-	Fingertips textured	Hand textured (Fully textured
surface from fingertips to end of
palm )	Different
Physical Properties	ASTM D6319	Meets	Meets
Before Aging
Tensile Strength:		28Mpa min	14MPa min	Different but
Ultimate Elongation:		500% min	500% min	within the ASTM
standard
After Aging
Tensile Strength:
Ultimate Elongation:		30Mpa min
480% min	14MPa min
400% min	Different but
within the ASTM
standard
Thickness :

Finger
Palm
Cuff | ASTM D6319 | 0.10mm
0.06mm
0.04mm | 0.05mm min
0.05mm min
0.05mm min | Different but
within the ASTM
standard | |
| Powder Free | ASTM D6124 | Less than 2mg per glove | Less than 2mg per glove | Same | |
| CHARACTERISTICS STANDARDS | DEVICE PERFORMANCE | | | COMPARISON ANALYSIS | |
| | PREDICATE | SUBJECT DEVICE | | | |
| | BLUE | DERMAGRIP POWDER FREE BLACK
NITRILE PATIENT EXAMINATION
GLOVE, NON-STERILE, TESTED FOR
USE WITH CHEMOTHERAPY DRUGS
AND FENTANYL RESISTANCE | | | |
| Primary Skin Irritation
ISO 10993-10:2010
(E) & Consumer
Product Safety
Commission Title 16.
Chapter II, Part 1500 | Non Irritating | Passes (Not a primary skin
irritant)
There was no erythema or
oedema noted on test site after
(24±2), (48±2) and (72±2)
hours. The primary Irritation
Index (PII) was "0" | | Similar | |
| Biocompatibility | Dermal Sensitization-
ISO 10993-10: 2010
(E) & Consumer
Product Safety
Commission, Title 16,
Chapter II, Part
1500.3 (c) (4) | Non Sensitization | Passes (Not a contact
sensitizer).
There was no positive allergic
reaction observed during the
challenge phase (at 0, 24
hours and 48 hours) in animals
treated with the test material
and negative control. | Similar | |
| | Cytotoxicity - MEM
Elution, ISO 10993-5:
2009 (E) | Non Cytotoxic | Acute systemic toxicity testing
performed to demonstrate
safety. | Different | |

6

7

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON
ANALYSIS |
|---------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | | PREDICATE
BLUE | SUBJECT DEVICE | |
| | | | DERMAGRIP POWDER FREE BLACK
NITRILE PATIENT EXAMINATION
GLOVE, NON-STERILE, TESTED FOR
USE WITH CHEMOTHERAPY DRUGS
AND FENTANYL RESISTANCE | |
| Biocompatibility | Acute Systemic
Toxicity, ISO 10993-
11:2017 (E) | Not Available | It is concluded that the product
did not induce any systemic
toxicity. | Different |
| Watertight (1000ml) | ASTM D5151:2019 | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Same |
| Intended use | - | A patient examination glove is a
disposable device intended for
medical purposes that is worn
on the examiner's hand to
prevent contamination between
patient and examiner. | A 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. | Same |
| Size | Medical Glove
Guidance Manual -
Labeling | X Small
Small
Medium
Large
Extra Large | X Small
Small
Medium
Large
Extra Large | Same |
| Single use | Medical Glove
Guidance Manual -
Labeling | Single use | Single use | Same |

8

		DEVICE PERFORMANCE
CHARACTERISTICS	STANDARD	PREDICATE	SUBJECT DEVICE	COMPARISON ANALYSIS
	S	BLUE	DERMAGRIP POWDER FREE BLACK
NITRILE PATIENT EXAMINATION
GLOVE, NON-STERILE, TESTED FOR
USE WITH CHEMOTHERAPY DRUGS
AND FENTANYL RESISTANCE
Chemotherapy Drugs		Minimum Breakthrough	Minimum Breakthrough
Permeation Test		Detection Time in Minutes	Detection Time in Minutes
Carmustine (BCNU) (3.3mg/ml)		10.1	21.1	Different
Cisplatin (1.0mg/ml)		>240	>240	Same
Cyclophosphamide (Cytoxan) (20.0mg/ml)		>240	>240	Same
Cytarabine (100.0mg/ml)		>240	Not Available	Different
Dacarbazine (10.0mg/ml)		>240	>240	Same
Doxorubicin Hydrochloride (2.0mg/ml)		>240	>240	Same
Etoposide (Toposar) (20.0mg/ml)		>240	>240	Same
Fluorouracil (50.0mg/ml)	ASTM
D6978	>240	>240	Same
Ifosfamide (50.0mg/ml)		>240	>240	Same
Methotrexate (25.0mg/ml)		>240	>240	Same
Mitoxantrone (2.0mg/ml)		>240	>240	Same
Mitomycin C (0.5mg/ml)		>240	>240	Same
Paclitaxel (Taxol) (6.0mg/ml)		>240	>240	Same
*Thiotepa (10.0mg/ml)		30.2	34.6	Different
Vincristine Sulfate (1.0mg/ml)		>240	>240	Same
Warning Statement		Please note that Carmustine (BCNU)
has extremely low permeation times
of 10.1 minutes	WARNING: Please note the following
drugs have extremely low permeation
times: Carmustine (BCNU): 21.1 minutes
and Thiotepa: 34.6. Do not use with
Carmustine and Thiotepa.	Different
Fentanyl Resistant (100mcg/2ml)	ASTM D6978	No breakthrough up to 240 minutes	No breakthrough up to 240 minutes	Same

9

There are no significant differences between the two products and are identical in terms of intended use, materials design, manufacturing methods except for color, physical properties and thickness.

7.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.

10

| Test

Method	Standard	Purpose of Testing	Acceptance Criteria
Physical
Properties	ASTM D412
(Standard Test
Method for
Vulcanized Rubber
and Thermoplastic
Elastomers-Tension)	To evaluate the
tensile (tension)
properties of glove.	Tensile
strength	Min 14.0
MPa	Min 14.0
MPa	Pass	Pass
			Ultimate
elongation	Min
500%	Min
400%	Pass	Pass

| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | | Results |
|----------------|-------------------------------------|-------------------------------------|--------------------------|---------------------|---------|
| Dimension | ASTM D3767
Standard Practice for | To measure the
length, width and | Length
(all sizes) | Min 240 mm | Pass |
| | Rubber- | thickness
of | Width | XS: ≤ 80 mm | Pass |
| | Measurement of | glove | | S: 80 ± 10 | Pass |
| | Dimensions | | | M: 95 ± 10 | Pass |
| | | | | L: 110 ± 10 | Pass |
| | | | | XL: ≥ 110 | Pass |
| | | | Thickness
(all sizes) | Finger: Min 0.05 mm | Pass |
| | | | | Palm: Min 0.05 mm | Pass |
| | | | | Cuff: Min 0.05 mm | Pass |

11

| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results |
|----------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|---------|
| Watertight | ASTM D5151
(Standard Test
Method for
Detection of Holes
in Medical Gloves) | To detect holes
that leak water
and thereby
compromise the
usefulness of the
glove. | Sample size: 500 pcs
Inspection level: G1
AQL: 1.5, Acceptance No. 10,
Found 2 | Pass |

| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results |
|--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|---------|
| Residual
Powder | ASTM D6124
(Standard Test
Method for Residual
Powder on Medical
Gloves) | To determine the
amount of
residual powder
and non-powder
solids found on
gloves. | Less than 2 mg per glove | Pass |

12

8.0 Summary of Clinical Testing:

No clinical study is included in this submission.

9.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrate that the subject device (Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance) is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K183287.