Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes surgical gloves and their testing for chemotherapy drug permeation. There is no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

No
This device is a surgical glove intended to protect operating room personnel from contamination, not to treat or diagnose a disease or condition.

Diagnostic

No.
The device description clearly states that these are surgical gloves intended for protection, not for diagnosing any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (surgical gloves made of synthetic polyisoprene rubber) and the performance studies focus on physical properties and biological reactivity. There is no mention of software components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to protect operating room personnel and a surgical wound from contamination. This is a barrier function, not a diagnostic one.
Device Description: The device is a surgical glove made of synthetic rubber. It's designed for physical protection.
Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
Testing for Chemotherapy Drugs: The testing for chemotherapy drug permeation is related to the glove's barrier properties and safety for the user, not for diagnosing anything.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical glove does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Product codes

KGO

Device Description

Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents

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

operating room personnel

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 to verify that the subject device will meet the acceptance criteria of the performance test shown below.

Results Summary:

Dimensions: Meets ASTM D3577 requirements for length, width and thickness.
- Length: Average 301mm (Minimum 265mm)
- Palm Width (size):
  - 5.5: Average 74 (70±6)
  - 6.0: Average 80 (76±6)
  - 6.5: Average 86 (83±6)
  - 7.0: Average 92 (89±6)
  - 7.5: Average 97 (95±6)
  - 8.0: Average 103 (102±6)
  - 8.5: Average 111 (108±6)
  - 9.0: Average 119 (114±6)
- Thickness:
  - Finger: 0.233 (Minimum 0.10)
  - Palm: 0.172 (Minimum 0.10)
  - Cuff: 0.212 (Minimum 0.10)
Physical Properties: Meets ASTM D3577-09 requirements for tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves.
Freedom from holes: Meets ASTM D3577-09 and ASTM D5151-06 requirements of AQL 1.5.
Powder-Free: Meets Applicable requirement for Powder Free; ≤ 2 mg per glove.
Sterility: Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6SAL.
Biocompatibility:
- ISO in vitro cytotoxicity: Under the conditions of the study, the device was found to be cytotoxic and therefore the device extracts were evaluated by ISO 10993-11 - Test for systemic toxicity. From Acute Systemic Toxicity device extracts, the device extracts did not elicit a systemic response in the animal model.
- ISO Skin Irritation Study: Under the conditions of the study, not an irritant.
- ISO Maximization Sensitization Study: Under the conditions of the study, not a sensitizer.
- ISO Systemic Toxicity Study: Under the conditions of the study, there was no mortality or evidence of systemic toxicity.
Chemotherapy Permeation Standard: Under the conditions of the study, the permeation is acceptable.

Key Metrics

Average Breakthrough Detection Times (Minutes) for Chemotherapy drugs:

Blenoxane, 15 mg/ml: >240
Busulfan, 6 mg/ml: >240
Carmustine (BCNU), 3.3 mg/ml: 10.2
Cisplatin , 1.0 mg/ml: >240
Cyclophosphamide (Cytoxan), 20.0 mg/ml: >240
Cytarabine , 100 mg/ml: >240
Dacarbazine (DTIC), 10.0 mg/ml: >240
Daunorubicin , 5 mg/ml: >240
Docetaxel, 10.0 mg/ml: >240
Doxorubicin Hydrochloride, 2.0 mg/ml: >240
Etoposide (Toposar), 20.0 mg/ml: >240
Fludarabine , 25 mg/ml: >240
Fluorouracil , 50.0 mg/ml: >240
Gemcitabine (Gemzar), 38 mg/ml: >240
Idarubicin , 1 mg/ml: >240
Ifosfamide , 50.0 mg/ml: >240
Irinotecan , 20.0 mg/ml: >240
Mechlorethamine HCI, 1.0 mg/ml: >240
Melphalan, 5 mg/ml: >240
Methotrexate , 25 mg/ml: >240
Mitomycin C, 0.5 mg/ml: >240
Mitoxantrone, 2.0 mg/ml: >240
Oxaliplatin , 2.0 mg/ml: >240
Paclitaxel (Taxol), 6.0 mg/ml: >240
Paraplatin , 10 mg/ml: >240
Thiotepa , 10.0 mg/ml: 11.5
Vincristine Sulfate, 1.0 mg/ml: >240
Ellence 2 mg/ml: >240
Rituximab, 10 mg/ml: >240
Note: Carmustine (BCNU): 10.2 minutes and Thiotepa: 11.5 minutes.

Predicate Device(s)

K111139

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).

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.

May 23, 2019

Ansell Healthcare Products, LLC. Don Cronk Director, Regulatory Affairs for the Americas 2301 Robb Drive Reno, Nevada 89523

Re: K190018

Trade/Device Name: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: April 16, 2019 Received: April 17, 2019

Dear Don Cronk:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

For David Krause, PhD Acting 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) K190018

Device Name

Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

Test Chemotherapy drug & Concentration	Average Breakthrough Detection Times(Minutes)
Blenoxane, 15 mg/ml	>240
Busulfan, 6 mg/ml	>240
Carmustine (BCNU), 3.3 mg/ml	10.2
Cisplatin , 1.0 mg/ml	>240
Cyclophosphamide (Cytoxan), 20.0 mg/ml	>240
Cytarabine , 100 mg/ml	>240
Dacarbazine (DTIC), 10.0 mg/ml	>240
Daunorubicin , 5 mg/ml	>240
Docetaxel, 10.0 mg/ml	>240
Doxorubicin Hydrochloride, 2.0 mg/ml	>240
Etoposide (Toposar), 20.0 mg/ml	>240
Fludarabine , 25 mg/ml	>240
Fluorouracil , 50.0 mg/ml	>240
Gemcitabine (Gemzar), 38 mg/ml	>240
Idarubicin , 1 mg/ml	>240
Ifosfamide , 50.0 mg/ml	>240
Irinotecan , 20.0 mg/ml	>240
Mechlorethamine HCI, 1.0 mg/ml	>240
Melphalan, 5 mg/ml	>240
Methotrexate , 25 mg/ml,	>240
Mitomycin C, 0.5 mg/ml	>240
Mitoxantrone, 2.0 mg/ml	>240
Oxaliplatin , 2.0 mg/ml	>240
Paclitaxel (Taxol), 6.0 mg/ml	>240
Paraplatin , 10 mg/ml	>240
Thiotepa , 10.0 mg/ml	11.5
Vincristine Sulfate, 1.0 mg/ml	>240
Ellence 2 mg/ml	>240
Rituximab, 10 mg/ml	>240

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 10.2 minutes and Thiotepa: 11.5 minutes.

Warning: Do not use with Carmustine and Thiotepa

3

] 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.

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

510K Summary K190018

Submitter:

Ansell Healthcare Products LLC. 2301 Robb Drive Reno, NV 89523 USA

Contact Person:

Don Cronk Director of Regulatory Affairs Phone: 775-470-7106 don.cronk@ansell.com

Date Prepared: April 16th, 2019

Name of Device

Trade Names:

	for Use with Chemotherapy Drugs
Common Name:	Surgeon's Gloves
Classification Name:	Surgeon's Gloves
Classification Regulation:	21 CFR 878.4460
Device Class:	I
Product Code:	KGO
Classification Panel:	General and Plastic Surgery
510k:	K190018

Legally Marketed Predicate Device

K111139 - Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs.

Gammex Non Latex Polyisoprene White Surgical Gloves Tested

Device Description

Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents

Indication for Use Statement

Gammex Non Latex PI White Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

5

Chemotherapy drug Permeation

(Average breakthrough detection time in minutes) (ASTM D6978-05)

| TEST CHEMOTHERAPY DRUG AND
CONCENTRATION | MINIMUM
BREAKTHROUGH
DETECTION TIME
(Sample 1,2,3)
(Minutes) |
|------------------------ | Blenoxane (15 mg/ml) | Busulfan (6 mg/ml) | Carmustine (BCNU) (3.3 mg/ml) | Cisplatin (1.0 mg/ml) | Cyclophosphamide | Cytarabine (100 mg/ml) | Dacarbazine (DTIC) (10.0 mg/ml) | Daunorubicin (5 mg/ml) | Docetaxel (10.0 mg/ml) | Doxorubicin Hydrochloride | Etoposide (Toposar) (20.0 mg/ml) | Fludarabine (25 mg/ml) | Fluorouracil (50.0 mg/ml) | Gemcitabine (Gemzar) (38 mg/ml) | Idarubicin (1 mg/ml) | Ifosfamide (50.0 mg/ml) | Irinotecan (20.0 mg/ml) | Mechlorethamine HCI (1.0 mg/ml) | Melphalan (5 mg/ml) | Methotrexate (25 mg/ml) | Mitomycin C (0.5 mg/ml) | Mitoxantrone (2.0 mg/ml) | Oxaliplatin (2.0 mg/ml) | Paclitaxel (Taxol) (6.0 mg/ml) | Paraplatin (10 mg/ml) | Thiotepa (10.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) | Ellence (2 mg/ml) | Rituximab (10 mg/ml) ---------------------|--------------------------------------------------------------------------|
| >240 |
| >240 |
| 10.2 |
| >240 |
(Cytoxan) (20.0 mg/ml) | >240 |
| >240 |
| >240 |
| >240 |
| >240 |
(2.0 mg/ml) | >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| >240 |
| 11.5 |
| >240 |
| >240 |
| >240 |

6

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 10.2 minutes and Thiotepa: 11.5 minutes.

Warning: Do not use with Carmustine and Thiotepa

Technological Characteristics

Technical Characteristic Comparison Table
Predicate Device	Subject Device	Comparison
Trade Name	Derma Prene Isotouch Green Sterile
Powder-Free Polyisoprene Surgical
Gloves, Tested for Use with
Chemotherapy Drugs.	Gammex® Non-Latex PI White	Different
510(k) Number	K111139	K190018	Different
Submitter	Ansell Healthcare Products LLC	Ansell Healthcare Products LLC	Same
Product Code	KGO	KGO	Same
Regulation
Number	21 CFR 878.4460	21 CFR 878.4460	Same
Regulation
Name	Non-powdered Surgeon's glove	Non-powdered Surgeon's glove	Same
Indications
for Use	Indications For Use:
These gloves are intended to be
worn by operating room personnel
to protect a surgical wound from
contamination, and are tested for
use with chemotherapy drugs.	These gloves are intended to be worn by operating
room personnel to protect a surgical wound from
contamination. These gloves were tested for use
with Chemotherapy Drugs as per ASTM D6978-05
Standard Practice for Assessment of Medical Gloves
to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:	Similar
with the
exception
of added
Chemoth-
erapy
drugs
Chemotherapy Drug Permeation
(average breakthrough detection
time in minutes) (ASTM D6978-05)	TEST CHEMOTHERAPY
DRUG AND
CONCENTRATION	MINIMUM
BREAKTHROUGH
DETECTION
TIME
	*Carmustine
15.5
Cyclophosphamide

240
Doxorubicm Hydrochloride >240
Etoposide (Toposar)
240
5-Fluorouracil
240
Paclitaxel (Taxol)
240
*ThioTEPA Methotrexate
15.5
Vincristine Sulfate
240 | Blenoxane (15
240
mg/ml)
Busulfan (6 mg/ml)
240
Carmustine (BCNU)
10.2
(3.3 mg/ml)
Cisplatin (1.0 mg/ml)
240
Cyclophosphamide
240
(Cytoxan) (20.0 | |

7

| Please note that Carmustine and
ThioTEPA have an extremely low
permeation time of 15.5 minutes. | Cytarabine (100
mg/ml) | >240 |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------|------|
| | Dacarbazine (DTIC)
(10.0 mg/ml) | >240 |
| | Daunorubicin (5
mg/ml) | >240 |
| | Docetaxel (10.0
mg/ml) | >240 |
| | Doxorubicin
Hydrochloride (2.0
mg/ml) | >240 |
| | Etoposide (Toposar)
(20.0 mg/ml) | >240 |
| | Fludarabine (25
mg/ml) | >240 |
| | Fluorouracil (50.0
mg/ml) | >240 |
| | Gemcitabine
(Gemzar) (38 mg/ml) | >240 |

8

		Idarubicin (1 mg/ml)	>240
		Ifosfamide (50.0
mg/ml)	>240
		Irinotecan (20.0
mg/ml)	>240
		Mechlorethamine HCI
(1.0 mg/ml)	>240
		Melphalan (5 mg/ml)	>240
		Methotrexate (25
mg/ml)	>240
		Mitomycin C (0.5
mg/ml)	>240
		Mitoxantrone (2.0
mg/ml)	>240
		Oxaliplatin (2.0
mg/ml)	>240
		Paclitaxel (Taxol) (6.0
mg/ml)	>240
		Paraplatin (10 mg/ml)	>240
		Thiotepa (10.0 mg/ml)	11.5
		Vincristine Sulfate (1.0
mg/ml)	>240
		Ellence (2 mg/ml)	>240
		Rituximab (10 mg/ml)	>240
Prescription
or Over-
The
Counter-
Use	Over-The-Counter-Use	Over-The-Counter-Use	Same
Materials	Synthetic polyisoprene rubber	Synthetic polyisoprene rubber	Same
Coating	Polyurethane polymer inner coating to
aid donning	Polyurethane polymer inner coating to
aid donning	Same
Performance	Meets ASTM D3577-09	Same	Same
Design	Single use	Single use	Same
	Sterile	Sterile	Same
	Powder-free	Powder-free	Same
	Hand Specific	Hand Specific	Same
	Beaded cuff	Beaded cuff	Same
Color	Green	White	Different
Dimensions and
physical
properties	Meets ASTM D3577	Meets ASTM D3577	Same
Sterilization
method	Radiation	Radiation	Same
Sterility
Assurance Level
(SAL)	10-6 SAL	10-6 SAL	Same
Freedom from
holes	Meets ASTM D3577-
09(2015)
Inspection level/AQL: GI/AQL 1.5	Meets ASTM D3577-
09(2015)
Inspection level/AQL: GI/AQL 0.65	Similar
Powder-Free	Meets ASTM D 6124-06. Meets
Applicable Definition for Powder Free; ≤ 2
mg per glove	Meets ASTM D 6124-06 The averaged
residual powder content for the glove
during process validation is 0.16mg per
glove	Same
Primary Skin
Irritation
ISO 10993-
10:2010	Under the conditions of the study (per
ISO 10993-10), the device is not an
irritant	Under the conditions of the study (per
ISO 10993-10), the device is not an
irritant	Same
Dermal
Sensitization -
ISO 10993-
10:2010	Under the conditions of the study (per
ISO 10993-10), not a sensitizer	Under the conditions of the study (per
ISO 10993-10), not a sensitizer	Same
Acute Systemic
Toxicity - ISO
10993-11: 2006	Under the conditions of the study, there
was no mortality or evidence of systemic
toxicity	Under the conditions of the study, there
was no mortality or evidence of systemic
toxicity	Same
Shelf Life	3 years	3 years	Same

9

The subject device is manufactured from synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning. The predicate device is manufactured from synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning.

Non-Clinical Testing Summary:

Non-clinical testing was performed to verify that the subject device will meet the acceptance criteria of the performance test shown below.

10

Technological Characteristics	Standard/Test/FDA Guidance	Result Summary
Dimensions	ASTM D3577	Meets ASTM D3577
requirements for length,
width and thickness
Length	Minimum 265mm	Average 301mm
Palm Width (size)	(mm)	Average value in mm
5.5	70±6	74
6.0	76±6	80
6.5	83±6	86
7.0	89±6	92
7.5	95±6	97
8.0	102±6	103
8.5	108±6	111
9.0	114±6	119
Thickness	(mm)	Average value in mm
Finger	Minimum 0.10	0.233
Palm	Minimum 0.10	0.172
Cuff	Minimum 0.10	0.212
Physical Properties	ASTM D3577-09	Meets ASTM D3577-09
requirements for tensile
strength, ultimate
elongation and stress at
500% elongation before
and after accelerated aging
for synthetic surgical gloves
Freedom from holes	ASTM D3577-09
ASTM D5151-06	Meets ASTM D3577-09
and ASTM D5151- 06
requirements of AQL 1.5
Powder-Free	ASTM D3577-09
ASTM D6124-06	Meets Applicable
requirement for Powder
Free; ≤ 2 mg per glove
Sterility	ANSI/AAMI/ISO 11137-1:2006	Meets ANSI/AAMI/ISO
11137-1:2006 requirement
of 10-6SAL
Technological Characteristics	Standard/Test/FDA Guidance	Result Summary
Biocompatibility:
ISO in vitro cytotoxicity	ISO 10993-5:2009	Under the conditions of the
study, the device was found
to be cytotoxic and
therefore the device
extracts were evaluated by
ISO 10993-11 - Test for
systemic toxicity. From
Acute Systemic Toxicity
device extracts, the device
extracts did not elicit a
systemic response in the
animal model.
ISO Skin Irritation Study	ISO 10993-10:2010	Under the conditions of the
study, not an irritant
ISO Maximization Sensitization
Study	ISO 10993-10:2010	Under the conditions of the
study, not a sensitizer
ISO Systemic Toxicity Study	ISO 10993-11:2006	Under the conditions of the
study, there was no
mortality or evidence of
systemic toxicity
Chemotherapy Permeation
Standard	ASTM D6978 - 05(2013)	Under the conditions of the
study, the permeation is
acceptable

11

12

The subject device meets the applicable requirements for surgeon's gloves with regard to dimensions and sizes, physical properties, freedom from holes, powder residues, and protein content as found in the following standards: ASTM D3577, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, irritation, and acute systemic toxicity in accord with the ISO 10993-10 and ISO 10993-11.

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.