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 barrier function of examination gloves, with no mention of AI or ML.

Therapeutic

No.
The device is an examination glove, intended to prevent contamination and protect the wearer, not to treat a disease or condition.

Diagnostic

No
The device is described as a "specialty medical glove" intended to create a physical barrier to prevent contamination and protect the wearer from chemotherapy drugs. There is no mention of it being used to diagnose diseases or conditions.

SaMD (Software as a Medical Device)

No

The device described is a physical medical glove, not a software application. The description focuses on material properties, physical barriers, and testing against chemotherapy drugs.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
Device's Intended Use: The intended use of these gloves is to act as a physical barrier between an examiner and a patient, and to protect the wearer from chemotherapy drugs. This is a protective barrier function, not a diagnostic function performed on a specimen.
Device Description: The description focuses on the physical properties and barrier function of the gloves. There is no mention of analyzing biological samples or providing diagnostic information.
Performance Studies: The performance studies described relate to the physical properties of the gloves and their resistance to chemotherapy drugs, not to the accuracy of a diagnostic test.

The device is a medical glove intended for protection and barrier purposes, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:

	Average Breakthrough Detection Time (minutes)
Cisplatin 1.0 mg/ml	≥ 240
Cyclophosphamide (Cytoxan) 20 mg/ml	≥ 240
Dacarbazine (DTIC) 10.0 mg/ml	≥ 240
Doxorubicin Hydrochloride 2.0 mg/ml	≥ 240
Etoposide (Toposar) 20.0 mg/ml	≥ 240
Fluorouracil 50.0 mg/ml	≥ 240
Paclitaxel (Taxol) 6.0 mg/ml	≥ 240

Please note that the following drugs have extremely low permeation time for
*Carmustine (BCNU) 3.3mg.ml - 23.4 (mins)
*Thiotepa 10.0 mg/ml - 16.2 (mins)

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

LZC, LZA

Device Description

The proposed device is the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green). The proposed device is for single use and is provided non-sterile. The device meets the requirements for dimensions, physical properties, and thickness in ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application. The device accomplishes its intended function by creating a physical barrier between the examiner and patient and creates a barrier for the chemotherapy drugs listed in the Indications for Use.

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 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)

The non-clinical performance data included testing for:

Dimensions (ASTM D6319 - 10(2015)): Length-Min 240mm, Thickness palm and finger- Min 0.05mm. Meets requirements.
Physical Properties (ASTM D6319 - 10(2015)): Meets requirements.
Thickness - Finger, Palm (ASTM D6319 - 10(2015)): Meets requirements.
Powder Content (ASTM D6124 - 06(2011)): Meets requirements (≤ 2 mg/glove).
Chemotherapy Drug Permeation Test (ASTM D6978-05):
- Carmustine (BCNU) 3.3 mg/ml: 23.4 min
- Cisplatin 1.0 mg/ml: >240 min
- Cyclophosphamide (Cytoxan) 20 mg/ml: >240 min
- Dacarbazine (DTIC) 10.0 mg/ml: >240 min
- Doxorubicin Hydrochloride 2.0 mg/ml: >240 min
- Etoposide (Toposar) 20.0 mg/ml: >240 min
- Fluorouracil 50.0 mg/ml: >240 min
- Paclitaxel (Taxol) 6.0 mg/ml: >240 min
- Thiotepa 10.0 mg/ml: 16.2 min
Biocompatibility:
- Primary Skin Irritation (ISO 10993-10:2010): Passes. Non-irritating.
- Dermal Sensitization (ISO 10993-10:2010): Passes. Non-sensitization.
- Cytotoxicity and acute systemic toxicity (ISO 10993-5:2009, ISO 10993-5:2017): Passes. Certificate of Analysis for color imparting compound indicates it is non-cytotoxic and not systemically toxic.
Watertight (1000ml) (21 CFR 800.20, ASTM D5151): Passes.

Clinical data is not needed for the intended use for this device.

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.

K162405

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 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.

May 15, 2018

Comfort Rubber Gloves Industries Sdn. Bhd. Chan Yew Men QA & QMS Manager Lot 821, Jalan Matang 34750 Matang, Perak Malyasia

Re: K180476

Trade/Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: February 12, 2018 Received: February 22, 2018

Dear Chan Yew Men:

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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -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)

K180476

Device Name

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green)

Indications for Use (Describe)

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:

	Average Breakthrough Detection Time (minutes)
Cisplatin 1.0 mg/ml	≥ 240
Cyclophosphamide (Cytoxan) 20 mg/ml	≥ 240
Dacarbazine (DTIC) 10.0 mg/ml	≥ 240
Doxorubicin Hydrochloride 2.0 mg/ml	≥ 240
Etoposide (Toposar) 20.0 mg/ml	≥ 240
Fluorouracil 50.0 mg/ml	≥ 240
Paclitaxel (Taxol) 6.0 mg/ml	≥ 240

Please note that the following drugs have extremely low permeation time for

*Carmustine (BCNU) 3.3mg.ml - 23.4 (mins)

*Thiotepa 10.0 mg/ml - 16.2 (mins)

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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ATTACHMENT 2

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

3

510(k) SUMMARY

POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (GREEN)

1.0 Submitter:

Name	Comfort Rubber Gloves Industries Sdn. Bhd.
Address	Lot 821, Jalan Matang,
34750 Matang, Perak, Malaysia.
Malaysia.
Phone No.	605-847 2777
Fax No.	605-847 9108
Contact Person	Chan Yew Men (Mr.)
Date of Preparation:	April 17, 2018

2.0 Name of the Device

Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green)

Common Name	:	Patient Examination Gloves
Classification Name	:	Patient Examination Gloves (21 CFR 880.6250 product
code LZA)
Patient Examination Gloves Specialty (21 CFR 880.6250
product code LZC)
510(K) Number	:	K180476

3.0 Identification of The Legally Marketed Devices That equivalency is claimed:

Predicate

Device Name : Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White)

Company : Comfort Rubber Gloves Industries Sdn. Bhd.
: K162405 510(K) No.

4.0 Description of the Device:

The proposed device is the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green). The proposed device is for single use and is provided non-sterile. The device meets the requirements for dimensions, physical properties, and thickness in ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application. The device accomplishes its intended function by creating a

4

physical barrier between the examiner and patient and creates a barrier for the chemotherapy drugs listed in the Indications for Use.

5.0 Indication for Use of the Device

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) are a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested drugs are as follows:

	Average Breakthrough Detection Time (minutes)
Cisplatin 1.0 mg/ml	≥ 240
Cyclophosphamide (Cytoxan) 20 mg/ml	≥ 240
Dacarbazine (DTIC) 10.0 mg/ml	≥ 240
Doxorubicin Hydrochloride 2.0 mg/ml	≥ 240
Etoposide (Toposar) 20.0 mg/ml	≥ 240
Fluorouracil 50.0 mg/ml	≥ 240
Paclitaxel (Taxol) 6.0 mg/ml	≥ 240

Please note that the following drugs have extremely low permeation time for *Carmustine (BCNU) 3.3 mg/ml - 23.4 (mins) *Thiotepa 10.0 mg/ml - 16.2 (mins)

6.0 Summary of the Technological Characteristics of the Device:

The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1.

The chemotherapy claim is similar to the Predicate, which has a qloves thickness which complies with the ASTM standard ASTM D6319 - 10(2015): Standard Specification for Nitrile Examination Gloves for Medical Application.

CHARACTERISTIC	STANDARDS	DEVICE PERFORMANCE
Manufacturer(s)		Comfort Rubber
Gloves Industries
Sdn. Bhd	Comfort Rubber
Gloves Industries
Sdn. Bhd	Same
510(k) number		K162405	K180476
Dimension	ASTM D6319 -
10(2015)	Length-Min 240mm
Thickness palm and
finger- Min 0.05mm	Length-Min 240mm
Thickness palm and
finger- Min 0.05mm	Same
Physical Properties	ASTM D6319 -
10(2015)	Meets	Meets	Same
Thickness - Finger

Palm | ASTM D6319 -
10(2015) | Meets | Meets | Same |
| Powder Content | ASTM D6124 -
06(2011)
(≤ 2 mg/glove) | Meets | Meets | Same |

Comparison of technological characteristics with the predicate device

5

	CHARACTERISTIC	STANDARDS	DEVICE PERFORMANCE
			Predicate	Current	Comparison
			Powder Free Nitrile
Examination Gloves
Tested for Use with
Chemotherapy
Drugs Labeling
Claim (Blue)	Powder Free Nitrile
Examination Gloves
Tested for Use with
Chemotherapy
Drugs Labeling
Claim (Green)
	Chemotherapy Drug
Permeation Test	ASTM D6978-05
	Test Chemotherapy Drug	Concentration	Minimum Breakthrough Detection Time
(min)
	*Carmustine (BCNU)	3.3 mg/ml	18.2	23.4
	Cisplatin	1.0 mg/ml	>240	>240
	Cyclophosphamide (Cytoxan)	20 mg/ml	>240	>240
	Dacarbazine (DTIC)	10.0 mg/ml	>240	>240	Similar - The
	Doxorubicin Hydrochloride	2.0 mg/ml	>240	>240	chemotherapy
	Etoposide (Toposar)	20.0 mg/ml	>240	>240	drugs tested
	Fluorouracil	50.0 mg/ml	>240	>240	have similar
	Paclitaxel (Taxol)	6.0 mg/ml	>240	>240	breakthrough
	*Thiotepa	10.0 mg/ml	57.3	16.2	detection
	Warning Statement		* WARNING:
Please note that the
following drugs have
extremely low
permeation times
Carmustine (BCNU):
18.2 minutes and
Thiotepa: 57.3
minutes.	* WARNING:
Please note that the
following drugs have
extremely low
permeation times
Carmustine (BCNU):
23.4 minutes and
Thiotepa: 16.2
minutes.	times; the
drugs with low
permeation
times are the
same.

		DEVICE PERFORMANCE
CHARACTERISTIC	STANDARDS	Predicate	Current	Comparison
		Powder Free Nitrile
Examination Gloves
Tested for Use with
Chemotherapy
Drugs Labeling
Claim (White)	Powder Free Nitrile
Examination Gloves
Tested for Use with
Chemotherapy
Drugs Labeling
Claim (Green)
Chemotherapy Drug
Permeation Test	ASTM D6978-05
Test Chemotherapy Drug	Concentration	Minimum Breakthrough Detection Time
(min)
*Carmustine (BCNU)	3.3 mg/ml	24.0	23.4	Similar - The
chemotherapy
Cisplatin	1.0 mg/ml	>240	>240	chemotherapy
Cyclophosphamide (Cytoxan)	20 mg/ml	>240	>240	drugs tested
Dacarbazine (DTIC)	10.0 mg/ml	>240	>240	have similar
Doxorubicin Hydrochloride	2.0 mg/ml	>240	>240	breakthrough
Etoposide (Toposar)	20.0 mg/ml	>240	>240	detection
Fluorouracil	50.0 mg/ml	>240	>240	times; the
Paclitaxel (Taxol)	6.0 mg/ml	>240	>240	drugs with low
*Thiotepa	10.0 mg/ml	54.9	16.2	permeation

6

| | Please note that the
following drugs have
extremely low
permeation times
Carmustine (BCNU):
24.0 minutes and
Thiotepa: 54.9
minutes. | Please note that the
following drugs have
extremely low
permeation times
Carmustine (BCNU):
23.4 minutes and
Thiotepa: 16.2
minutes. | same. |

--	-----------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------	-------

CHARACTERISTIC	STANDARDS	DEVICE PERFORMANCE
		Predicate	Current
Biocompatibility:
Primary Skin Irritation	ISO 10993-
10:2010
Biological
evaluation of
medical devices --
Part 10: Tests for
irritation and skin
sensitization	Passes
Under the conditions
of the study, the
subject device is non-
irritating	Passes
Under the conditions
of the study, the
subject device is non-
irritating	Same
Biocompatibility:
Dermal Sensitization	ISO 10993-
10:2010
Biological
evaluation of
medical devices --
Part 10: Tests for
irritation and skin
sensitization	Passes
Under the conditions
of the study, the
subject device is non-
sensitization	Passes
Under the conditions
of the study, the
subject device is non-
sensitization	Same
Biocompatibility:
Cytotoxicity and acute
systemic toxicity	ISO 10993-5:2009
Biological
evaluation of
medical devices --
Part 5: Tests for in vitro cytotoxicity
ISO 10993-5:2017
Biological
evaluation of
medical devices --
Part 5: Tests for
systemic toxicity	N/A	Passes
Certificate of Analysis
for the color imparting
compound indicates
that the compound
meets technical
specifications, is non-
cytotoxic, and is not
systemically toxic.	Different
Watertight (1000ml)	21 CFR 800.20
ASTM D5151	Passes	Passes	Same
Indication for Use		The Powder Free
Nitrile Examination
Gloves Tested for
Use with
Chemotherapy Drugs
Labeling Claim (Blue)
is a specialty medical
glove which is a
disposable device
intended for medical
purpose that is worn
on the examiner's
hand or finger to
prevent	The Powder Free
Nitrile Examination
Gloves Tested for
Use with
Chemotherapy Drugs
Labeling Claim
(Green) is a specialty
medical glove which
is a disposable
device intended for
medical purpose that
is worn on the
examiner's hand or
finger	Similar

7

| contamination
between examiner
and patient. In
addition these gloves
are worn to protect
the wearer against
exposure to
chemotherapy drugs.
Tested
chemotherapy drugs
are as follows: | contamination
between examiner
and patient. In
addition these gloves
are worn to protect
the wearer against
exposure to
chemotherapy drugs.
Tested chemotherapy
drugs are as follows: | | examiner's hand or
finger to prevent
contamination
between examiner
and patient. In
addition these gloves
are worn to protect
the wearer against
exposure to
chemotherapy drugs.
Tested
chemotherapy drugs
are as follows: | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Average
Breakthrough
Detection Time
(minutes) | Average
Breakthrough
Detection Time
(minutes) | | Average
Breakthrough
Detection Time
(minutes) | |
| Cisplatin, 1.0 mg/ml -
≥ 240
Cyclophosphamide
(Cytoxan), 20.0
mg/ml - ≥ 240
Dacarbazine (DTIC),
10.0 mg/ml - ≥ 240
Doxorubicin
Hydrochloride, 2.0
mg/ml - ≥ 240
Etoposide (Toposar),
20.0 mg/ml - ≥ 240
Fluorouracil, 50.0
mg/ml - ≥ 240
Paclitaxel (Taxol), 6.0
mg/ml

≥ 240 | Cisplatin, 1.0 mg/ml -
≥ 240
Cyclophosphamide
(Cytoxan), 20.0
mg/ml - ≥ 240
Dacarbazine (DTIC),
10.0 mg/ml - ≥ 240
Doxorubicin
Hydrochloride, 2.0
mg/ml - ≥ 240
Etoposide (Toposar),
20.0 mg/ml - ≥ 240
Fluorouracil, 50.0
mg/ml - ≥ 240
Paclitaxel (Taxol), 6.0
mg/ml
≥ 240 | | Cisplatin, 1.0 mg/ml -
$\ge$ 240
Cyclophosphamide
(Cytoxan), 20.0
mg/ml - $\ge$ 240
Dacarbazine (DTIC),
10.0 mg/ml - $\ge$ 240
Doxorubicin
Hydrochloride, 2.0
mg/ml - $\ge$ 240
Etoposide (Toposar),
20.0 mg/ml - $\ge$ 240
Fluorouracil, 50.0
mg/ml - $\ge$ 240
Paclitaxel (Taxol), 6.0
mg/ml
$\ge$ 240 | |
| Please note that the
following drugs have
extremely low
permeation time for: | Please note that the
following drugs have
extremely low
permeation time for: | | Please note that the
following drugs have
extremely low
permeation time for: | |
| Carmustine (BCNU)
3.3mg/ml - 18.2
(mins)
Thiotepa 10.0 mg/ml
57.3 (mins) | Carmustine (BCNU)
3.3mg/ml - 23.4
(mins)
Thiotepa 10.0 mg/ml
16.2 (mins) | | Carmustine (BCNU)
3.3mg/ml - 24.0
(mins)
Thiotepa 10.0 mg/ml
54.9 (mins) | |
| The Powder Free
Nitrile Examination
Gloves Tested for
Use with
Chemotherapy Drugs
Labeling Claim
(White) is a specialty
medical glove which
is a disposable
device intended for
medical purpose that
is worn on the | | | | |

8

CHARACTERISTIC	STANDARDS	DEVICE PERFORMANCE
		Predicate	Current	Comparison
Material	ASTM D6319 -
10(2015)	Nitrile	Nitrile	Same
Color	-	Blue or White	Green	Different
Size	Medical Glove
Guidance Manual

Labeling | Extra Small
Small
Medium
Large | Extra Small
Small
Medium
Large | Same |

9

		Extra Large	Extra Large
Single Use	Medical Glove
Guidance Manual
– Labeling	Single Use	Single Use	Same

7.0 Summary of Non-Clinical Performance Data

The device and the predicate share the same indication for use, same base polymeric material, same specifications for thickness and length, similar permeation rate for chemotherapy drugs, similar labeling properties, biocompatibility per ISO 10993-1, water tight test results, and are powder free.

8.0 Summary of Clinical Performance Data

Clinical data is not needed for the intended use for this device.

9.0 Conclusion

Based on the Indication for Use, technological characteristics, and non-clinical performance data, the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) (K180476) is as safe, as effective, and performs as well as the legally marketed predicate device (K162405).