Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define the device as a standard patient examination glove, with no mention of AI or ML capabilities. The performance data focuses on barrier properties and resistance to chemotherapy drugs, not algorithmic performance.

Therapeutic

No
The device is a patient examination glove, which is intended to prevent contamination between patient and examiner and is not designed to treat or diagnose a medical condition.

Diagnostic

No

Explanation: The device is a patient examination glove, described as a barrier to prevent contamination, not to diagnose a medical condition. While it has "breakthrough detection time" as a metric, this refers to the glove's integrity against chemotherapy drugs, not its ability to detect patient conditions.

SaMD (Software as a Medical Device)

No

The device is a physical glove, not software. The description details material properties and testing for barrier function, which are characteristics of a hardware device.

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 clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to perform tests on samples taken from the human body to diagnose diseases or conditions.
Device Description: The description focuses on the physical properties and barrier function of the glove, and its compliance with standards for medical gloves and resistance to chemotherapy drugs. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Diagnostic claims or interpretation of results from biological samples
- Calibration or quality control procedures for diagnostic testing

The testing for chemotherapy drug permeation is a performance characteristic of the glove as a barrier device, not a diagnostic test.

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

Original Blue: A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
Cobalt Blue: A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

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

LZA, LZC

Device Description

Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or finger (worn on the examiner's hand or finger)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner / Medical purpose

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests performance data support a determination of substantial equivalence. The device complies with ASTM requirements, specifically ASTM D6319-10 for Medical Application, D6978-05 for assessment of resistance to permeation by chemotherapy drugs, and FDA 21 CFR 880.6250. Key results include:

Water tightness (1000ml): Passes (ASTM D5151-06)
Dimension: Min 240mm (ASTM D6319-10)
Physical Properties: Meets (ASTM D6319-10)
Powder-free: Meets ( 240 minutes
- Carmustine, 3.3 mg/ml: 1.84 minutes
- Cisplatin (BCNU), 1.0 mg/ml: > 240 minutes
- Cyclophosphamide (Cytoxan), 20.0 mg/ml: > 240 minutes
- Dacarbazine (DTIC), 10.0 mg/ml: > 240 minutes
- Doxorubicin Hydrochloride, 2.0 mg/ml: > 240 minutes
- Etoposide (Toposar), 20.0 mg/ml: > 240 minutes
- Fluorouracil, 50.0 mg/ml: > 240 minutes
- Ifosfamide, 50.0 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 (Taxol), 6.0 mg/ml: > 240 minutes
- ThioTEPA, 10.0 mg/ml: 0.76 minutes
- Vincristine Sulfate, 1.0 mg/ml: > 240 minutes
- Cobalt Blue:
  - Carboplatin, 10 mg/ml: > 240 minutes
  - Carmustine, 3.3 mg/ml: 1.82 minutes
  - Cisplatin (BCNU), 1.0 mg/ml: > 240 minutes
  - Cyclophosphamide (Cytoxan), 20.0 mg/ml: > 240 minutes
  - Dacarbazine (DTIC), 10.0 mg/ml: > 240 minutes
  - Doxorubicin Hydrochloride, 2.0 mg/ml: > 240 minutes
  - Etoposide (Toposar), 20.0 mg/ml: > 240 minutes
  - Fluorouracil, 50.0 mg/ml: > 240 minutes
  - Ifosfamide, 50.0 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 (Taxol), 6.0 mg/ml: > 240 minutes
  - ThioTEPA, 10.0 mg/ml: 0.93 minutes
  - Vincristine Sulfate, 1.0 mg/ml: > 240 minutes

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

Average Breakthrough Detection Time for various chemotherapy drugs, ranging from 0.76 minutes to > 240 minutes.

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

K141982, K151997

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three overlapping profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

YTY Industry (Manjung) Sdn. Bhd., Punitha Samy Deputy Manager-DC/RA Lot 1422-1424 Batu 10 Lekir Sitiawan, Perak 32020 MY

Re: K162095

Trade/Device Name: Non-sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Original Blue, Cobalt Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 19, 2016 Received: September 23, 2016

Dear Punitha Samy:

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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162095

Device Name

Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Original Blue

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 finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

Tested Chemotherapy Drug And Concentration	Average Breakthrough Detection Time
Carboplatin, 10 mg/ml	> 240 minutes
Carmustine (3.3 mg/ml)	1.84 minutes
Cisplatin (BCNU), 1.0 mg/ml	> 240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/ml	> 240 minutes
Dacarbazine (DTIC), 10.0 mg/ml	> 240 minutes
Doxorubicin Hydrochloride, 2.0 mg/ml	> 240 minutes
Etoposide (Toposar), 20.0 mg/ml	> 240 minutes
Fluorouracil, 50.0 mg/ml	> 240 minutes
Ifosfamide , 50.0 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 (Taxol), 6.0 mg/ml	> 240 minutes
ThioTEPA (10.0 mg/ml)	0.76 minutes
Vincristine Sulfate, 1.0 mg/ml	> 240 minutes

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 1.84 minutes ThioTEPA (10.0 mg/ml): 0.76 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162095

Device Name

Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue

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 finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

Tested Chemotherapy Drug And Concentration	Average Breakthrough Detection Time
Carboplatin, 10 mg/ml	> 240 minutes
Carmustine (3.3 mg/ml)	1.82 minutes
Cisplatin (BCNU), 1.0 mg/ml	> 240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/ml	> 240 minutes
Dacarbazine (DTIC), 10.0 mg/ml	> 240 minutes
Doxorubicin Hydrochloride, 2.0 mg/ml	> 240 minutes
Etoposide (Toposar), 20.0 mg/ml	> 240 minutes
Fluorouracil, 50.0 mg/ml	> 240 minutes
Ifosfamide , 50.0 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 (Taxol), 6.0 mg/ml	> 240 minutes
ThioTEPA (10.0 mg/ml)	0.93 minutes
Vincristine Sulfate, 1.0 mg/ml	> 240 minutes

The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 1.82 minutes ThioTEPA (10.0 mg/ml): 0.93 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.

5

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 Druq 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."

6

K162095

510 (K) SUMMARY SHEETS

1.0
2.0	Submitter	YTY INDUSTRY (MANJUNG) SDN. BHD.,
Lot 1422-1424, Batu 10 Lekir
32020 Sitiawan, Perak
Malaysia
	Tel	605-6908533
	Fax	605-6908533
	Name of Contact Person	Punitha Samy (Ms)
E-mail: punitha.samy@ytygroup.com.my
	Date Summary Prepared	November 2, 2016
3.0	Name of Device
	Trade Name:	Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves,
Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
	Common Name:	Nitrile Examination Gloves
	Classification Name:	Patient Examination Gloves, Powder Free
	Device Classification:	I
		Regulation No. & Classification Name: Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC)
Patient Examination Gloves (21 CFR 880.6250 product code LZA)

Panel:

General Hospital

4.0 Identification of The Legally Marketed Devices that equivalency is claimed:

| Device Name | Dermagrip Powder Free
Blue Nitrile Patient
Examination Gloves, Non-
Sterile, Tested for use with
Chemotherapy Drugs | Nitrile Powder Free
Examination Gloves Tested
for Use with
Chemotherapy Drugs -
Violet Blue (VBLU) |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Predicate 510(K)
number: | K141982 | K151997 |
| Device Classification: | 1 | 1 |
| Product Code: | LZC | LZC |

Sec 1 Sum Page 1 of 8

7

5.0 Description of The Device

Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

6.0 The Intended Use of Glove

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

| Characteristic | Concentration | K162095
Original Blue | K162095
Cobalt Blue |
|-------------------------------|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Average Breakthrough Detection Time (minutes) | |
| Carboplatin | 10mg/ml | > 240 | > 240 |
| *Carmustine | 3.3mg/ml | 1.84 | 1.82 |
| Cisplatin (BCNU) | 1.0mg/ml | > 240 | > 240 |
| Cyclophosphamide
(Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 |
| Doxorubicin
Hydrochloride | 2.0mg/ml | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 | > 240 |
| Methotrexate | 25mg/ml | > 240 | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 | > 240 |
| Mitoxantrone | 2 mg/ml | > 240 | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Thiotepa | 10.0mg/ml | 0.76 | 0.93 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | | *WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 1.84 minutes and ThioTepa: 0.76 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA | * WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 1.82 minutes and ThioTepa: 0.93 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA |

Sec 1 Sum Page 2 of 8

8

7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for substantial equivalent discussion

There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) have the below technological characteristic compared to ASTM or Equivalent standards.

This glove is compliant with the ASTM standards and similar to the predicate device in the market, which has a glove thickness less than 0.10mm and length less than 270mm. The chemotherapy claim is similar to Predicate.

Table 1 – Predicate 1
Characteristic	Standards	Device Performance
		Predicate K162095 – Original Blue
510(K) Number		K141982 K162095
Dimension	ASTM D6319-10	Min 240mm Min 240mm
Physical Properties	ASTM D6319-10	Meets Meets
Thickness	ASTM D6319-10	Finger 0.07 – 0.10mm 0.09 – 0.14mm
Palm 0.07 – 0.09mm 0.07 - 0.10mm
Cuff 0.06 – 0.08mm 0.06 – 0.09mm
Powder-free	ASTM D6124-06
( 240
*Carmustine	3.3mg/ml	15
Cisplatin	1.0mg/ml	> 240
Cyclophosphamide
(Cytoxan)	20.0mg/ml	> 240
Dacarbazine (DTIC)	10.0mg/ml	> 240
Doxorubicin
Hydrochloride	2.0mg/ml	> 240
Etoposide (Toposar)	20.0mg/ml	> 240
Fluorouracil	50.0mg/ml	> 240
Ifosfamide (Ifex)	50.0mg/ml	> 240
Methotrexate	25mg/ml	-
Mitomycin C	0.5mg/ml	-
Mitoxantrone	2 mg/ml	> 240
Paclitaxel (Taxol)	6.0mg/ml	> 240
Thiotepa	10.0mg/ml	2.0
Vincristine Sulfate	1.0mg/ml	> 240
Warning Statement		*WARNING: Please note that
the following drugs have
extremely low permeation
times: Carmustine (BCNU) :
15 minutes and Thiotepa : 2
minutes	*WARNING: Please note that
the following drugs have
extremely low permeation
times: Carmustine: 1.84
minutes and ThioTepa: 0.76
minutes. NOT TO BE USED
WITH CARMUSTINE OR
THIOTEPA

Table 2 – Predicate 1

Table 3 – Predicate 2

Characteristic	Standards	Device Performance
		Predicate	K162095 – Cobalt Blue
510(K) Number		K151997	K162095
Dimension	ASTM D6319-10	Min 240mm	Min 240mm
Physical Properties	ASTM D6319-10	Meets	Meets
Thickness	Finger	0.10min	0.10min
	Palm	0.07 – 0.09mm	0.07 – 0.09mm
	Cuff		0.05 - 0.08mm
Powder-free	ASTM D6124-06
( 240
*Carmustine	3.3mg/ml	10.2	1.82
Cisplatin	1.0mg/ml	> 240	> 240
Cyclophosphamide
(Cytoxan)	20.0mg/ml	> 240	> 240
Dacarbazine (DTIC)	10.0mg/ml	> 240	> 240
Doxorubicin
Hydrochloride	2.0mg/ml	> 240	> 240
Etoposide (Toposar)	20.0mg/ml	> 240	> 240
Fluorouracil	50.0mg/ml	> 240	> 240
Ifosfamide (Ifex)	50.0mg/ml	-	> 240
Methotrexate	25mg/ml	> 240	> 240
Mitomycin C	0.5mg/ml	> 240	> 240
Mitoxantrone	2 mg/ml	-	> 240
Paclitaxel (Taxol)	6.0mg/ml	> 240	> 240
Thiotepa	10.0mg/ml	30.2	0.93
Vincristine Sulfate	1.0mg/ml	> 240	> 240
Warning Statement		* Please note that
Carmustine and Thiotepa
have extremely low
permeation times of 10.2
minutes and 30.2
minutes	* WARNING: Please note that
the following drugs have
extremely low permeation
times: Carmustine: 1.82
minutes and ThioTepa: 0.93
minutes. NOT TO BE USED
WITH CARMUSTINE OR
THIOTEPA

Table 4 – Predicate 2

Sec 1 SUM Page 5 of 8

11

Table 5 Device Performance
Characteristics	Predicate
K141982	K162095
Original Blue	Predicate
K151997	K162095
Cobalt Blue	Medical Glove
Manual (1661) and
Standards
Water tightness
(1000ml)	Passes	Passes	Passes	Passes	ASTM D5151-06
Color	Blue	Original Blue	Violet Blue	Cobalt Blue	ASTM D6319-10
(Reapproved 2015)
Material	Nitrile	Nitrile	Nitrile	Nitrile	Labeling
Size	Extra Small
Small
Medium
Large
Extra Large	Extra Small
Small
Medium
Large
Extra Large	Extra Small
Small
Medium
Large
Extra Large	Extra Small
Small
Medium
Large
Extra Large	Labeling
Texture	Finger Textured	Finger Textured	Finger
Textured	Finger
Textured
Single Use	Single Use	Single Use	Single Use	Single Use	Labeling
Bio-compatibility	Passes	Passes	Passes	Passes	Primary Skin Irritation
	Not primary skin
irritant under the
conditions of the study.	Under the condition of the
study the device is non-irritant	Under the condition of
the study the device is
non-irritant	Under the condition of the
study the device is non-
irritant	ISO 10993-10: 2010(E)
Test for Irritation and
Skin Sensitization &
Consumer Product
Safety Commission II,
Part 1500
	Passes
Not a contact sensitizer
under the conditions of
the study.	Passes
Under the condition of the
study the device in non-
sensitizer	Passes
Under the condition of
the study the device in
non-sensitizer	Passes
Under the condition of the
study the device in non-
sensitizer	Dermal Sensitization -
ISO 10993-10(E) &
Consumer Product
Safety Commission,
Title 16, Chapter II,
Part 1500.3 (c) (4)

Tahle 5

Sec 1 SUM Page 6 of 8

12

| Indications for Use | A patient
Examination glove is a
medical device intended
for medical purposes
that is worn on the
examiner's hand to
prevent contamination
between patient and
examiner. | A patient examination gloves is a
disposable device intended for
medical purpose that is worn on the
examiner's hand or finger to
prevent contamination between
patient and examiner. This glove is
also tested for use against
Chemotherapy
Drugs. The Chemotherapy Drugs
and its permeation time is listed as
below. | Is nonsterile
disposable device
intended for medical
purpose that is worn on
the examiner's hand to
prevent contamination
between patient and
examiner. It is also
tested to be used against
Chemotherapy Drugs. | A patient examination gloves is a
disposable device intended for
medical purpose that is worn on the
examiner's hand or
finger to prevent contamination
between patient and examiner. This
glove is also tested for use against
Chemotherapy
Drugs. The Chemotherapy Drugs
and its permeation time is listed as
below. | This gloves meet all
current specifications
listed under ASTM
specifications D6319-10 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | *Carmustine3.3mg/ml15
Cisplatin 1.0mg/ml >
240
Cyclophosphamide
Cytoxan) 20.0mg/ml > | Tested Chemotherapy
Drug And Concentration | Carmustine (3.3 mg/ml)
10.2 minutes
Cisplatin (1.0 mg/ml) >240
minutes
Cyclophosphamide (20
mg/ml) >240 minutes
Dacarbazine (10.0 mglml)

240 minutes
Doxorubicin
Hydrochloride (2.0 mg/ml)
240 minutes
Etoposide (20.0 mg/ml)
240 minutes | Tested Chemotherapy
Drug And Concentration | | 240
Dacarbazine (DTIC)
10.0mg/ml> 240
Doxorubicin
Hydrochloride 2.0mg/ml>
240
Etoposide (Toposar)
20.0mg/ml> 240 Carmustine (3.3 mg/ml)
Cisplatin (BCNU), 1.0
mg/ml
Cyclophosphamide
(Cytoxan), 20.0 mg/ml
Dacarbazine (DTIC), 10.0
mg/ml Methotrexate (25 mg/ml) Carmustine (3.3 mg/ml)
Cisplatin (BCNU), 1.0
mg/ml
Cyclophosphamide
(Cytoxan), 20.0 mg/ml
Dacarbazine (DTIC), 10.0
mg/ml | 240
Ifosfamide (Ifex)
50.0mg/ml> 240 Hydrochloride, 2.0 mg/ml
Etoposide (Toposar), 20.0
mg/ml Hydrochloride, 2.0 mg/ml
Etoposide (Toposar), 20.0
mg/ml | 240
Paclitaxel (Taxol)
6.0mg/ml> 240
Thiotepa 10.0mg/ml 2.0 Ifosfamide , 50.0 mg/ml
Methotrexate, 25 mg/ml
Mitomycin C, 0.5 mg/ml
Mitoxantrone, 2 mg/ml 240 minutes
Paclitaxel (6.0 mg/ml)
240 minutes
Thiotepa (10.0 mg/ml)
30.2 minutes
Vincristine Sulfate (1.0
mg/ml) >240 minutes
Please note that
Carmustine and Thiotepa
have extremely low Ifosfamide , 50.0 mg/ml
Methotrexate, 25 mg/ml
Mitomycin C, 0.5 mg/ml
Mitoxantrone, 2 mg/ml | 1.0mg/ml> 240
Warning Statement mg/ml
ThioTEPA (10.0 mg/ml)
Vincristine Sulfate, 1.0 mg/ml
ThioTEPA (10.0 mg/ml) | that the following drugs
have extremely low The following The following | Carmustine (BCNU) : 15
minutes and Thiotepa : 2
minutes permeation time.
Carmustine (3.3 mg/ml): 1.84 min
ThioTEPA (10.0 mg/ml): 0.76 min permeation time.
Carmustine (3.3 mg/ml): 1.82 min
ThioTEPA (10.0 mg/ml): 0.93 min | | Break
through
Detection
Time Break
through
Detection
Time | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Carboplatin, 10 mg/ml
| Fluorouracil (50.0 mg/ml)
| Carboplatin, 10mg/ml
| |
| Fluorouracil 50.0mg/ml>
| Doxorubicin
| | Doxorubicin
| |
| Mitoxantrone 2 mg/ml>
| Fluorouracil, 50.0 mg/ml
| Mitomycin C (0.5 mg/ml)
| Fluorouracil, 50.0 mg/ml
| |
| Vincristine Sulfate
| Paclitaxel (Taxol), 6.0
| | Paclitaxel (Taxol), 6.0
| |
| *WARNING: Please note
| mg/ml
chemotherapy drugs and | | mg/ml
chemotherapy drugs and | |
| permeation times:
| concentration have extremely low
| | concentration have extremely low
| |
| Average
| | Average
| |
| >240 min | | >240 min | |
| 1.84 min | | 1.82 min | |
| >240 min | | >240 min | |
| >240 min | | >240 min | |
| >240 min | | >240 min | |
| >240 min | | >240 min | |
| >240 min | | >240 min | |
| >240 min | | >240 min | |
| >240 min | | >240 min | |
| >240 min | | >240 min | |
| >240 min | | >240 min | |
| 0.76 min | | 0.93 min | |
| >240 min | | >240 min | |

13

8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The non-clinical tests performance data support a determination of substantial equivalence is the same as and in compliance to ASTM requirements.

9.0 Conclusion

The conclusions drawn from the intended uses, technological characteristics and non-clinical tests demonstrate that the subject device is substantially equivalent to the predicate device K141982 and K151997.

Sec 1 SUM Page 8 of 8