Predicate Devices

Reference Devices

Not Mentioned

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical examination glove and the description focuses on material properties and testing for chemotherapy drug permeation, with no mention of AI or ML.

Therapeutic

No
A therapeutic device is used to treat or alleviate a medical condition. This device is an examination glove, which is a barrier for protection during examinations, not a treatment.

Diagnostic

No
The device, JR Medic Blue Nitrile Examination Gloves, is described as a disposable device intended for medical purposes, specifically "worn on the examination between patient and examiner," and tested for use with chemotherapy drugs to prevent permeation. Its function is to provide a barrier for protection, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of nitrile, which is a hardware component. The description focuses on the physical properties and testing of the glove material.

IVD (In Vitro Diagnostic)

Based on the provided text, 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 examination between patient and examiner." This describes a barrier device for protection during medical examinations.
Device Description: The device is described as a "patient examination glove made from acrylonitrile-butadiene copolymer dispersion... powder free and non sterile". This is consistent with a medical glove.
Lack of IVD Characteristics: An IVD device is 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 function. Its purpose is a physical barrier.
Testing for Chemotherapy Drugs: While the gloves are tested for resistance to chemotherapy drugs, this testing relates to the protective function of the glove for the user, not to any diagnostic or analytical function on a patient sample.

Therefore, the JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs are a medical device, specifically a patient examination glove, but they do not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs. The tested chemotherapy drugs and their breakthrough detection times are as follows:

Tested Chemotherapy Drug Name & Concentration	Minimum Breakthrough Detection Time
Carmustine (BCNU) (3.3 mg/ml)	35.0 Minutes
Carboplatin (10 mg/ml)	>240 Minutes
Cisplatin (1 mg/ml)	>240 Minutes
Cyclophosphamide (Cytoxan) (20 mg/ml)	>240 Minutes
Dacarbazine (10.0 mg/ml)	>240 Minutes
Doxorubicin HCl (2 mg/ml)	>240 Minutes
Etoposide (20 mg/ml)	>240 Minutes
Fluorouracil (50 mg/ml)	>240 Minutes
Ifosfamide (50 mg/ml)	>240 Minutes
Methotrexate (25 mg/ml)	>240 Minutes
Mitomycin C (0.5 mg/ml)	>240 Minutes
Mitoxantrone (2 mg/ml)	>240 Minutes
Paclitaxel (6 mg/ml)	>240 Minutes
Thiotepa (10 mg/ml)	64.9 Minutes
Vincristine Sulfate (1 mg/ml)	>240 Minutes

Product codes

LZA, LZC, OPJ

Device Description

The subject device in 510(K) notification is JR Medic blue nitrile examination gloves powder free tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

Non-clinical testing was performed based on ASTM D6319-2019 for various physical properties (length, width, thickness, tensile strength, ultimate elongation, powder free residue) and ASTM D5151-2019 for watertightness. Biocompatibility testing was conducted based on ISO 10993-10 for irritation and skin sensitization, ISO 10993-5 for in vitro cytotoxicity, and ISO 10993-11 for systemic toxicity and material mediated pyrogenicity. The gloves were also tested for permeation by chemotherapy drugs in accordance with ASTM D6978-05 (2019) to determine minimum breakthrough detection times for various chemotherapy drugs.

Length of the gloves:
- Small: 404 mm
- Medium: 405 mm
- Large: 405 mm
- X-Large: 406 mm
Width of the gloves:
- Small: 84 mm
- Medium: 94 mm
- Large: 105 mm
- X-Large: 115 mm
Thickness of the gloves:
- Palm: 0.19mm for all sizes
- Finger: 0.21mm for all sizes
Physical Properties (Tensile Strength):
- Before Ageing:
  - Small: 22.77Mpa
  - Medium: 24.46Mpa
  - Large: 24.51Mpa
  - X-Large: 24.59Mpa
- After Ageing:
  - Small: 20.50Mpa
  - Medium: 21.81Mpa
  - Large: 21.95Mpa
  - X-Large: 22.05Mpa
Physical Properties (Ultimate Elongation):
- Before Ageing:
  - Small: 885%
  - Medium: 888%
  - Large: 891%
  - X-Large: 892%
- After Ageing:
  - Small: 868%
  - Medium: 870%
  - Large: 872%
  - X-Large: 875%
Watertight: Gloves Passes AQL-1.5
Residual Powder: 0.16 mg/glove for all sizes
Biocompatibility:
- Primary Skin Irritation: Under the condition of study not an irritant.
- Dermal Sensitization: Under the conditions of the study not a sensitizer.
- In vitro cytotoxicity: Under the conditions of the study cytotoxic.
- Acute Systemic Toxicity Test: Under the conditions of study the device extracts do not pose a systemic toxicity concern.
- Material Mediated Pyrogenicity: Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time):
- Carmustine (BCNU) (3.3 mg/ml): 35.0 Minutes
- Carboplatin (10 mg/ml): >240 Minutes
- Cisplatin (1 mg/ml): >240 Minutes
- Cyclophosphamide (Cytoxan) (20 mg/ml): >240 Minutes
- Dacarbazine (10.0 mg/ml): >240 Minutes
- Doxorubicin HCl (2 mg/ml): >240 Minutes
- Etoposide (20 mg/ml): >240 Minutes
- Fluorouracil (50 mg/ml): >240 Minutes
- Ifosfamide (50 mg/ml): >240 Minutes
- Methotrexate (25 mg/ml): >240 Minutes
- Mitomycin C (0.5 mg/ml): >240 Minutes
- Mitoxantrone (2 mg/ml): >240 Minutes
- Paclitaxel (6 mg/ml): >240 Minutes
- Thiotepa (10 mg/ml): 64.9 Minutes
- Vincristine Sulfate (1 mg/ml): >240 Minutes

Key Metrics

Watertight (1000 ml): Passes AQL-1.5
Powder Free Residue:

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.

December 6, 2021

JR Engineering & Medical Technologies (M) SDN.BHD. Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504

Re: K212827

Trade/Device Name: Jr Medic Blue Nitrile Examination Powder Free 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, OPJ Dated: November 2, 2021 Received: November 4, 2021

Dear Manoj Zacharias:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For 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 Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K212827

Device Name

JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs

Indications for Use (Describe)

JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examination between patient and examiner.

Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Tested Chemotherapy Drug Name & Concentration	Minimum Breakthrough Detection Time
Carmustine (BCNU) (3.3 mg/ml)	35.0 Minutes
Carboplatin (10 mg/ml)	>240 Minutes
Cisplatin (1 mg/ml)	>240 Minutes
Cyclophosphamide (Cytoxan) (20 mg/ml)	>240 Minutes
Dacarbazine (10.0 mg/ml)	>240 Minutes
Doxorubicin HCl (2 mg/ml)	>240 Minutes
Etoposide (20 mg/ml)	>240 Minutes
Fluorouracil (50 mg/ml)	>240 Minutes
Ifosfamide (50 mg/ml)	>240 Minutes
Methotrexate (25 mg/ml)	>240 Minutes
Mitomycin C (0.5 mg/ml)	>240 Minutes
Mitoxantrone (2 mg/ml)	>240 Minutes
Paclitaxel (6 mg/ml)	>240 Minutes
Thiotepa (10 mg/ml)	64.9 Minutes
Vincristine Sulfate (1 mg/ml)	>240 Minutes

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

510(K) SUMMARY K212827 As required by: 21CFR§807.92(c)

A. APPLICANTINFORMATION

510(K) Owner's Name	JR Engineering & Medical Technologies (M) SDN.BHD.
Address	Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1,
Pusat Perindustrian 2, 44200 Rasa, Hulu Selangor, Selangor
Darul Ehsan, Malaysia.
Phone	+603-60572081
Fax	+603-60572181
E-mail	ganeshjrmt@gmail.com
Contact Person	Mr. Ganesan Subramaniam
Designation	Managing Director
Contact Number	+6012 224 6677
Contact Email	ganeshjrmt@gmail.com
Date Submitted	02 NOV 2021

B. DEVICE IDENTIFICATION

| Name of the device | JR Medic Blue Nitrile Examination Gloves Powder
Free tested for use with Chemotherapy drugs |
|-----------------------------------|------------------------------------------------------------------------------------------------|
| Product proprietary or trade name | JR MEDIC |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves, Specialty |
| Device Classification | Class I |
| Product Code | LZC, LZA, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

C. PREDICATE DEVICE

| Predicate Device | Harbour Health
Powder Free Nitrile Examination Glove, Blue (Tested for
use with Chemotherapy Drugs) |
|------------------|-----------------------------------------------------------------------------------------------------------|
| 510(K) Number | K210944 |
| Regulatory Class | 1 |
| Product code | LZA, LZC, OPJ |

D. DESCRIPTION OF THEDEVICE:

The subject device in 510(K) notification is JR Medic blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I).

5

The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)

E. INTENDED USE OF THE DEVICE:

JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

| Tested Chemotherapy Drug Name &
Concentration | Minimum Breakthrough Detection
Time (Minutes) |
|--------------------------------------------------|--------------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 35.0 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes

Warning: Do not use with Carmustine (BCNU) & Thiotepa

6

F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE		REMARKS
		PREDICATE	PROPOSED
DEVICE
510(K) Number	-	K210944	K212827
Name of device	-	Harbour Health
Powder Free
Nitrile
Examination
Glove, Blue
(Tested for use
with
Chemotherapy
Drugs)	JR Medic
Blue Nitrile
Examination Gloves
Powder Free tested
for use with
Chemotherapy drugs	Similar
Product Code	-	LZA, LZC, OPJ	LZC, LZA, OPJ	Similar
Intended use	-	Harbour Health
Powder Free
Nitrile
Examination
Glove, Blue
(Tested for use
with
Chemotherapy
Drugs) disposable
device intended for
medical purpose that
is worn on the
examiner's hand to
prevent
contamination
between patient
and examiner.
The proposed
device was tested
for use with
chemotherapy
drugs as per
ASTM D6978-05
(2019), Standard
Practice for
Assessment of
Medical Gloves to
Permeation by
Chemotherapy
Drugs	JR Medic Blue
Nitrile Examination
Gloves Powder Free
tested for use with
Chemotherapy drugs
is a disposable
device intended for
medical purpose that
is worn on the
examiner's hand to
prevent
contamination
between patient and
examiner.
Additionally, the
gloves were tested
for use with
chemotherapy drugs
in accordance with
ASTM D6978-05
(2019) Standard
Practice for
Assessment of
Medical Glove to
Permeation by
Chemotherapy
Drugs.	Similar
CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE		REMARKS
		PREDICATE
K210944	PROPOSED
DEVICE
K212827
Regulation Number	-	21 CFR
880.6250	21 CFR
880.6250	Same
Material	-	Nitrile	Nitrile	Same
Color	-	Blue	Blue	Same
Texture	-	Finger Texture	Finger texture	Same
Size	ASTM D6319-
2019	Small, Medium,
Large, Extra
Large	Small, Medium,
Large, Extra
Large	Same
Single Use	Medical Glove
Guidance
Manual

Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Dimensions | ASTM D6319-
2019 | Length: Small-
Min 220 mm &
Medium, Large
& Extra large-
Min 230 mm
Width Min
95+/-10 mm(
Medium Size) | Length > 230
mm
Width Min
95+/-10 mm(for
medium size) | Similar |
| Physical Properties | ASTM D6319-
2019 | Before Ageing
Tensile Strength
min 14 Mpa
Ultimate
Elongation
Min 500%
After Ageing
Tensile Strength
min 14 Mpa
Ultimate
Elongation
Min 400% | Before Ageing
Tensile Strength

14 Mpa
Ultimate
Elongation
500%
After Ageing
Tensile Strength
14 Mpa
Ultimate
Elongation
400% | Thickness 2019 min 0.05 mm
Finger
min 0.05 mm Finger > 0.05
mm | Powder Free
Residue 2019 conditions of the
study non
pyrogenic | Toxicity Test ISO
10993-11:2017(E) the study, the device
does not elicit a
systemic toxicity
response in the model
animal of study does not
induce any systemic
toxic concern | Chemotherapy Drugs 05 (2019) | | Busulfan (6mg/ml) | Carmustine (BCNU) (3.3 mg/ml) | Carboplatin (10 mg/ml) | Cisplatin (1 mg/ml) | Cyclophosphamide | Cytarabine (100 mg/ ml) | Dacarbazine (10.0 mg/ml) | Docetaxel (10 mg/ml) | Doxorubicin HCl (2 mg/ml) | Etoposide (20 mg/ml) | Fluorouracil (50 mg/ml) | Ifosfamide (50 mg/ml) | Mechlorethamine
HCL (1 mg/ml) | Methotrexate (25 mg/ml) | Mitomycin C (0.5 mg/ml) | Mitoxantrone (2 mg/ml) | Paclitaxel (6 mg/ml) | Thiotepa (10 mg/ml) | Vincristine Sulfate (1 mg/ml) | Same |
| ASTM D6319-
| Palm
| Palm >0.05 mm
| Same |
| ASTM D6319-
| | No Data Available | Under the
| ---- |
| Acute Systemic
| Under the conditions of
| Under the condition
| Similar |
Tested with Minimum Breakthrough Detection Time as tested per ASTM D6978-
| | | |
| | >240 Minutes | Not Tested | Different |
| | 14.5 Minutes | 35.0 Minutes | Different |
| | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | >240 Minutes | Same |
(Cytoxan) (20 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | Not Tested | Different |
| | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | Not Tested | Different |
| | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | Not Tested | Different |
| | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | >240 Minutes | Same |
| | >240 Minutes | >240 Minutes | Same |
| | 47.4 Minutes | 64.9 Minutes | Different |
| | >240 Minutes | >240 Minutes | Same |

7

8

9

Test Method	Purpose	Acceptance Criteria	Result
ASTM D6319-2019 Standard
Specification for Nitrile
Examination Gloves for
Medical Application	To determine the
length of the gloves	Min 220 mm for Size Small
& Min 230 mm for all
other sizes	Small:- 404 mm
Medium:- 405 mm
Large:- 405 mm
X-Large:- 406 mm
ASTM D6319-2019 Standard
Specification for Nitrile
Examination Gloves for
Medical Application	To determine the
width of the gloves	Small:- 80+/-10 mm
Medium:- 95+/-10mm
Large:- 110+/-10 mm
X-Large:- 120+/-10 mm	Small:- 84 mm
Medium:- 94 mm
Large:- 105 mm
X-Large:- 115 mm

G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA

Test Method	Purpose	Acceptance Criteria
ASTM D6319-2019 Standard
Specification for Nitrile
Examination Gloves for
Medical Application	To determine the
thickness of the
gloves	Palm 0.05 mm min
Finger 0.05 mm min
for all sizes	Size Palm Finger
Small 0.19mm 0.21mm
Medium 0.19mm 0.21mm
Large 0.19mm 0.21mm
X-Large 0.19mm 0.21mm
ASTM D6319-2019 Standard
Specification for Nitrile
Examination Gloves for
Medical Application	To Determine the
physical properties-
Tensile strength	Before Ageing
Tensile Strength
14Mpa Min for all
sizes
After Ageing Tensile
Strength 14Mpa Min
for all sizes	Size Before
ageing After
ageing
Small 22.77Mpa 20.50Mpa
Medium 24.46Mpa 21.81Mpa
Large 24.51Mpa 21.95Mpa
X-Large 24.59Mpa 22.05Mpa
		Before Ageing
Ultimate Elongation
500% Min for all
sizes
After Ageing
Ultimate Elongation
400% Min for all
sizes	Size Before
ageing After
ageing
Small 885% 868%
Medium 888% 870%
Large 891% 872%
X-Large 892% 875%

10

Test Method	Purpose	Acceptance Criteria
ASTM D5151-2019 Standard
Test Method for Detection of
Holes in Medical Gloves	To determine the
holes in the gloves	AQL 2.5	Gloves Passes AQL 1.5
ASTM D6124-06 (Reapproved

Standard Test Method
for Residual Powder on
Medical Gloves | To determine the
residual powder in
the gloves | 2 Mg/Glove Max | Size
Small 0.16 mg/glove
Medium 0.16 mg/glove
Large 0.16 mg/glove
X-Large 0.16mg/glove |

H. BIO-COMPATIBILITY DATA

Test Method	Purpose	Acceptance Criteria	Result
ISO 10993-10 Biological
Evaluation of Medical Devices
Test for Irritation and Skin
Sensitization. Test done for
irritation.	To determine the potential of
the material under test to
produce dermal irritation in
Rabbits	Under the condition
of study not an
irritant	Under the condition of
study not an irritant
ISO 10993-10 Biological
Evaluation of Medical Devices
Test for Irritation and Skin
Sensitization. Test done Skin
sensitization.	To determine the skin
sensitization potential of the
material both in terms of
induction and elicitation in
Guinea Pig.	Under the
conditions of the
study not a
sensitizer	Under the conditions of
the study not a
sensitizer
ISO 10993-5:2009 biological
evaluation of medical devices -
part 5, tests for in vitro
cytotoxicity.	To evaluate the in vitro
cytotoxic potential of the test
item (both inner and outer
surface) Extracts in L-929
mouse fibroblasts cells using
elution method.	Under the
conditions of study
non cytotoxic	Under the conditions of
the study cytotoxic.
ISO 10993-11:2017 biological
evaluation of medical devices -
part 11, tests for systemic
toxicity.	To determine the acute
systemic toxicity potential of
the test item extracts (both
inside and outer surfaces) in
Swiss Albino mice.	Under the
conditions of study
the device extracts
do not pose a
systemic toxicity
concern	Under the conditions
of study the device
extracts do not pose a
systemic toxicity
concern
Material Mediated
Pyrogenicity ISO 10993-
11:2017(E) / USP 41	To determine the pyrogenic
potential of the test item
extract following intravenous
injection in New Zealand
white Rabbits.	Under the
conditions of the
study, the device
did not
demonstrate a
material mediated
pyrogenicity
response.	Under the conditions of
the study, the device did
not demonstrate a
material mediated
pyrogenicity response.

11

I. Clinical Testing Summary

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.

J. CONCLUSION

The conclusions drawn from the non clinical test demonstrate that the subject device in 510(K) submission, JR Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is as safe, as effective, and performs as well as the legally marketed predicate device Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for use with Chemotherapy Drugs) K210944.