Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on material properties, testing for chemical resistance and biocompatibility, and physical characteristics of surgical gloves. There is no mention of any computational analysis, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No.
The device (surgical gloves) is intended to protect operating room personnel and surgical wounds, not to treat a disease or condition.

Diagnostic

No

The device description and intended use clearly state that these are surgical gloves designed for protection during surgery, not for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device is described as surgical gloves made of polyisoprene rubber, which are physical objects and not software.

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 a surgical wound from contamination by being worn by operating room personnel. This is a barrier function, not a diagnostic one.
Device Description: The description details the physical characteristics of surgical gloves.
Performance Studies: The performance studies focus on the physical properties, safety (biocompatibility, sensitization), and barrier function (chemotherapy permeation) of the gloves. There are no studies related to analyzing samples from the human body for diagnostic purposes.
Lack of Diagnostic Elements: There is no mention of analyzing blood, tissue, or other bodily fluids, or providing information about a patient's health status.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

These 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, have low dermatitis potential, and are non-pyrogenic. 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	Breakthrough Detection Time (Minutes)
Bleomycin (15 mg/ml)	>240
Busulfan (6 mg/ml)	>240
Carmustine (BCNU) (3.3 mg/ml)	12.6
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)	26.6
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) 12.6 minutes and Thiotepa: 26.6 minutes. Warning Do not use with Carmustine and Thiotepa

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

KGO, LZC, OPJ

Device Description

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing:

Dimensions:
- Purpose: To evaluate the dimension of the glove (length, palm width, thickness).
- Standard/Test/FDA Guidance Criteria: ASTM D3577 (Minimum 265mm length, specific palm widths for sizes 5.5-9.0, Minimum 0.10mm thickness for Finger, Palm, and Cuff).
- Result Summary: Pass for all dimensions.
Physical Properties:
- Purpose: To evaluate the tensile strength, ultimate elongation, and stress at 500% elongation.
- Standard/Test/FDA Guidance Criteria: ASTM D3577-19 (Meets ASTMD3577-19 requirements before and after accelerated aging for synthetic surgical gloves).
- Result Summary: Pass.
Freedom from holes:
- Purpose: To evaluate the presence of holes in the gloves.
- Standard/Test/FDA Guidance Criteria: ASTM D3577-19 ASTM D5151-06 (Meets ASTM D3577-19 and ASTM D5151-06 requirements, AQL 1.5).
- Result Summary: Pass.
Powder-Free:
- Purpose: To evaluate the level of powder on the gloves.
- Standard/Test/FDA Guidance Criteria: ASTM D3577-19 ASTM D6124-06 (Meets applicable requirement for Powder Free; ≤ 2 mg per glove).
- Result Summary: Pass.
Sterility:
- Purpose: To demonstrate the sterilization performance.
- Standard/Test/FDA Guidance Criteria: ANSI/AAMI/ISO 11137-1:2018 (Meets ANSI/AAMI/ISO 11137-1:2018 requirement of 10-6 SAL).
- Result Summary: Pass.
Biocompatibility: ISO in vitro cytotoxicity:
- Purpose: To evaluate cytotoxicity.
- Standard/Test/FDA Guidance Criteria: ISO 10993-5:2009 (Non-cytotoxic).
- Result Summary: 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 acute systemic response in the animal model.
Biocompatibility: ISO Skin Irritation Study:
- Purpose: To demonstrate low skin irritation potential.
- Standard/Test/FDA Guidance Criteria: ISO 10993-10:2010 (Under the conditions of the study, not an irritant).
- Result Summary: Pass.
Biocompatibility: ISO Maximization Sensitization Study:
- Purpose: To demonstrate low sensitization potential.
- Standard/Test/FDA Guidance Criteria: ISO 10993-10:2010 (Under the conditions of the study not a sensitizer).
- Result Summary: Pass.
Biocompatibility: ISO Acute Systemic Toxicity Study:
- Purpose: To demonstrate no acute systemic toxicity.
- Standard/Test/FDA Guidance Criteria: ISO 10993-11:2006 (Under the conditions of the study, there was no mortality or evidence of acute systemic toxicity).
- Result Summary: Pass.
Chemotherapy Permeation Standard:
- Purpose: To demonstrate chemotherapy drug barrier performance.
- Standard/Test/FDA Guidance Criteria: ASTM D6978 - 05(2019) (Under the conditions of the study the permeation is acceptable for the drugs tested for use with the subject gloves).
- Result Summary: Pass.
Human Skin Sensitization:
- Purpose: To demonstrate low dermatitis potential.
- Standard/Test/FDA Guidance Criteria: Modified Draize-95 Test (Under the conditions of the study, not a sensitizer).
- Result Summary: Pass.
Endotoxin Study:
- Purpose: To demonstrate low endotoxin levels.
- Standard/Test/FDA Guidance Criteria: Less than 20.0 EU/device.
- Result Summary: Pass.
Material Mediated Pyrogenicity Study:
- Purpose: To demonstrate low pyrogenicity potential.
- Standard/Test/FDA Guidance Criteria: ISO 10993-11:2017 (Under the conditions of the study, has met the material mediated pyrogenicity requirement).
- Result Summary: Pass.

Clinical Summary:

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis potential were tested in accordance with Modified Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510k] Submissions for Testing Skin Sensitization Chemicals in Natural Rubber Products 1999". Both the inner and the outer surfaces of the subject glove were tested. The results showed low dermatitis potential for the human subject tested.

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

Chemotherapy Drug Permeation (Minimum breakthrough detection time in minutes):
- Blenoxane (15 mg/ml): >240
- Busulfan (6 mg/ml): >240
- Carmustine (BCNU) (3.3 mg/ml): 12.6
- 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): 26.6
- Vincristine Sulfate (1.0 mg/ml): >240
- Ellence (2 mg/ml): >240
- Rituximab (10 mg/ml): >240
Sterility Assurance Level (SAL): 10-6 SAL
Freedom from holes: Meets ASTM D3577-09(2015), Inspection level/AQL: GI/AQL 1.5
Powder-Free: Meets ASTM D 6124-06. Meets Applicable Definition for Powder Free; ≤ 2 mg per glove
In Vitro Cytotoxicity: Failed. Cytotoxicity Grade 4.
Biocompatibility Primary Skin Irritation ISO 10993-10:2010: Under the conditions of the study (per ISO 10993-10), the device is not an irritant.
Biocompatibility Dermal Sensitization - ISO 10993-10:2010: Under the conditions of the study (per ISO 10993-10), not a sensitizer.
Biocompatibility Acute Systemic Toxicity - ISO 10993-11: 2006: Under the conditions of the study, there was no mortality or evidence of acute systemic toxicity.
Material-Mediated Pyrogenicity: Under the conditions of the study, both inner and outer surface is non-pyrogenic.
Bacterial Endotoxin: Under the conditions of the study, test results indicate low endotoxin level.
Low Dermatitis Potential: Under the conditions of the study, the test results demonstrated low dermatitis potential for the subject glove.

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.

K190018

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

§ 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 23, 2023

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

Re: K230079

Trade/Device Name: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: July 20, 2023 Received: July 24, 2023

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

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

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

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

Sincerely,

Bifeng Qian -S

BiFeng Qian, M.D., Ph.D Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K230079

Device Name

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential

Indications for Use (Describe)

These 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, have low dermatitis potential, and are nonpyrogenic. 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	Breakthrough Detection Time (Minutes)
Bleomycin (15 mg/ml)	>240
Busulfan (6 mg/ml)	>240
Carmustine (BCNU) (3.3 mg/ml)	12.6
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)	26.6
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) 12.6 minutes and Thiotepa: 26.6 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)

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4

510K Summary

K230079 Submitter: Ansell Healthcare Products LLC. 2301 Robb Drive Reno, NV 89523 USA

Contact Person(s):

Don Cronk Assoc. Director, Regulatory Phone: 775-750-1723 don.cronk@ansell.com

Carson Delaloye Sr. Administrator, Quality Phone: 530-401-8977 carson.delaloye@ansell.com

Date Prepared: August 23, 2023

Name of Device

| Trade Names: | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
and Low Dermatitis Potential |
|----------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Surgeon's Gloves |
| Classification Name: | Non-Powdered Surgeon's Glove |
| Classification Regulation: | 21 CFR 878.4460 |
| Device Class: Product | I |
| Code: Classification | KGO, LZC, OPJ |
| Panel: 510k Number | General and Plastic Surgery |
| Assigned: | K230079 |

Legally Marketed Predicate Device

K190018-Gammex Non-Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

Device Description

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.

Indication for Use Statement

These 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, have low dermatitis potential, and are non-pyrogenic. 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.

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 12.6 minutes and Thiotepa: 26.6 minutes. Warning Do not use with Carmustine and Thiotepa.

5

Chemotherapy Drug Permeation

(Minimum breakthrough detection time in minutes) (ASTM D6978-05 2019)

| TEST CHEMOTHERAPY DRUG AND
CONCENTRATION | MINIMUM
BREAKTHROUGH
TIME (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) | >240 | 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 |
| 12.6 |
| >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 |
| 26.6 |
| >240 |
| >240 |
| >240 |

6

	Technical Characteristic Comparison Table
	Predicate Device		Subject Device	Comparison
Trade Name	Gammex Non-Latex PI White
Polyisoprene Surgical Gloves Tested for
Use with Chemotherapy Drugs		Polyisoprene Surgical Glove Tested
for Use with Chemotherapy Drugs and
Low Dermatitis Potential	Different
510(k) Number	K190018		K230079	Different
Submitter	Ansell Healthcare Products LLC		Ansell Healthcare Products LLC	Same
Product Code	KGO		KGO, LZC, OPJ	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	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.		These 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, have low dermatitis
potential, and are non-pyrogenic. 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.	Similar
	Tested chemotherapy drugs are as follows:
TESTCHEMOTHERAPY
DRUGAND
CONCENTRATION	MINIMUM
BREAKTHROUGH
DETECTION
TIME (Minutes)	TEST CHEMOTHERAPY
DRUGAND
CONCENTRATION	MINIMUM
BREAKTHROUGH
TIME (Minutes)
	Blenoxane (15
mg/ml)	>240	Blenoxane (15
mg/ml)	>240
	Busulfan (6 mg/ml)	>240	Busulfan (6 mg/ml)	>240
	Carmustine(BCNU)
(3.3 mg/ml)	10.2	Carmustine (BCNU)
(3.3 mg/ml)	12.6
	Cisplatin (1.0 mg/ml)	>240	Cisplatin (1.0 mg/ml)	>240
	Cyclophosphamide
(Cytoxan) (20.0
mg/ml)	>240	Cyclophosphamide
(Cytoxan) (20.0
mg/ml)	>240
	Cytarabine (100
mg/ml)	>240	Cytarabine (100
mg/ml)	>240
	Dacarbazine (DTIC)
(10.0 mg/ml)	>240	Dacarbazine (DTIC)
(10.0 mg/ml)	>240
	Daunorubicin (5
mg/ml)	>240	Daunorubicin (5
mg/ml)	>240
	Docetaxel (10.0
mg/ml)	>240	Docetaxel (10.0
mg/ml)	>240
	Doxorubicin
Hydrochloride (2.0
mg/ml)	>240	Doxorubicin
Hydrochloride (2.0
mg/ml)	>240
	Etoposide (Toposar)
(20.0 mg/ml)	>240	Etoposide (Toposar)
(20.0 mg/ml)	>240
	Fludarabine (25
mg/ml)	>240	Fludarabine (25
mg/ml)	>240
	Fluorouracil (50.0
mg/ml)	>240	Fluorouracil (50.0
mg/ml)	>240
	Gemcitabine
(Gemzar) (38 mg/ml)	>240	Gemcitabine
(Gemzar) (38 mg/ml)	>240
	Idarubicin (1 mg/ml)	>240	Idarubicin (1 mg/ml)	>240
	Ifosfamide (50.0
mg/ml)	>240	Ifosfamide (50.0
mg/ml)	>240
	Irinotecan (20.0
mg/ml)	>240	Irinotecan (20.0
mg/ml)	>240
	Mechlorethamine HCI
(1.0 mg/ml)	>240	Mechlorethamine HCI
(1.0 mg/ml)	>240
	Melphalan (5 mg/ml)	>240	Melphalan (5 mg/ml)	>240
	Methotrexate (25
mg/ml)	>240	Methotrexate (25
mg/ml)	>240
	Mitomycin C (0.5
mg/ml)	>240	Mitomycin C (0.5
mg/ml)	>240
	Mitoxantrone (2.0
mg/ml)	>240	Mitoxantrone (2.0
mg/ml)	>240
	Oxaliplatin (2.0
mg/ml)	>240	Oxaliplatin (2.0
mg/ml)	>240
	Paclitaxel (Taxol) (6.0
mg/ml)	>240	Paclitaxel (Taxol) (6.0
mg/ml)	>240
	Paraplatin (10 mg/ml)	>240	Paraplatin (10 mg/ml)	>240
	Thiotepa (10.0 mg/ml)	11.5	Thiotepa (10.0 mg/ml)	26.6
	Vincristine Sulfate (1.0
mg/ml)	>240	Vincristine Sulfate (1.0
mg/ml)	>240
	Ellence (2 mg/ml)	>240	Ellence (2 mg/ml)	>240
	Rituximab (10 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		Please note that the following drugs have
extremely low permeation times:
Carmustine (BCNU) 12.6 minutes and
Thiotepa: 26.6 minutes. Warning Do not
use with Carmustine and Thiotepa
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
Design	Single use		Single use		Same
	Powder-free		Powder-free		Same
	Hand Specific		Hand Specific		Same
	Beaded cuff		Beaded cuff		Same
Color	White		White		Same
Sizes	5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0		5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0		Same
Dimensions and
physical
properties	Meets ASTM D3577		Meets ASTM D3577		Same
Sterility	Sterile		Sterile		Same
Sterilization
method	Irradiation		Irradiation		Same

7

8

| 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 1.5	Similar
Powder-Free	Meets ASTM D 6124-06. Meets
Applicable Definition for Powder Free; ≤ 2
mg per glove	Meets ASTM D 6124-06. Meets
Applicable Definition for Powder Free; ≤ 2 mg per glove	Same
Protein Content	Not Applicable	Not Applicable	Same
In Vitro
Cytotoxicity	Failed. Cytotoxicity Grade 4.	Failed. Cytotoxicity Grade 4.	Same
Biocompatibility
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
Biocompatibility
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
Biocompatibility
Acute Systemic
Toxicity - ISO
10993-11: 2006	Under the conditions of the study, there
was no mortality or evidence of acute
systemic toxicity	Under the conditions of the study,
there was no mortality or evidence
of acute systemic toxicity	Same
Material-
Mediated
Pyrogenicity	No pyrogenicity claims made	Under the conditions of the study,
both inner and outer surface is
non-pyrogenic	Different
Bacterial
Endotoxin	No endotoxin claims	Under the conditions of the study,
test results indicate low endotoxin
level	Different
Low Dermatitis
Potential	No low dermatitis potential claims made	Under the conditions of the study,
the test results demonstrated low
dermatitis potential for the subject
glove.	Different

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.

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

10

Summary of Non-clinical Testing

| Technological
Characteristics | Purpose | Standard/Test/FDA Guidance
Criteria | Result Summary |
|-----------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | To evaluate the
dimension of the glove | ASTM D3577
Meets ASTM D3577 requirements
for length, width and thickness | Pass |
| Length | | Minimum 265mm | Pass |
| Palm Width (size) | | (mm) | Pass |
| 5.5 | | 70±6 | Pass |
| 6.0 | | 76±6 | Pass |
| 6.5 | | 83±6 | Pass |
| 7.0 | | 89±6 | Pass |
| 7.5 | | 95±6 | Pass |
| 8.0 | | 102±6 | Pass |
| 8.5 | | 108±6 | Pass |
| 9.0 | | 114±6 | Pass |
| Thickness | To evaluate the thickness
of the glove | (mm) | Pass |
| Finger | | Minimum 0.10 | Pass |
| Palm | | Minimum 0.10 | Pass |
| Cuff | | Minimum 0.10 | Pass |
| Physical
Properties | To evaluate the tensile
strength, ultimate
elongation, and stress at
500% elongation | ASTM D3577-19
Meets ASTMD3577-19
requirements for tensile strength,
ultimate elongation and stress at
500% elongation before and after
accelerated aging for synthetic
surgical gloves | Pass |
| Freedom from
holes | To evaluate the presence
of holes in the gloves | ASTM D3577-19 ASTM D5151-06
Meets ASTM D3577-19
and
ASTM D5151-06 requirements
AQL 1.5 | Pass |
| Powder-Free | To evaluate the level of
powder on the gloves | ASTM D3577-19 ASTM D6124-06
Meets applicable requirement for
Powder Free; ≤ 2 mg per glove | Pass |
| Sterility | To demonstrate the
sterilization performance | ANSI/AAMI/ISO 11137-1:2018
Meets ANSI/AAMI/ISO 11137-
1:2018 requirement of 106 SAL | Pass |
| Technological
Characteristics | To Evaluate | Standard/Test/FDA Guidance | Result Summary |
| Biocompatibility: | | | |
| ISO in vitro
cytotoxicity | To evaluate
cytotoxicity | ISO 10993-5:2009
Non-cytotoxic | Under the conditions o
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 acute systemic
response in the animal
model. |
| ISO Skin Irritation
Study | To demonstrate low skin
irritation potential | ISO 10993-10:2010
Under the conditions of the study,
not an irritant | Pass |
| ISO Maximization
Sensitization Study | To demonstrate low
sensitization potential | ISO 10993-10:2010
Under the conditions of the study
not a sensitizer | Pass |
| ISO Acute
Systemic
Toxicity Study | To demonstrate no
acute systemic
toxicity | ISO 10993-11:2006
Under the conditions of the study,
there was no morality or evidence
of acute systemic toxicity | Pass |
| Chemotherapy
Permeation
Standard | To demonstrate
chemotherapy drug
barrier performance | ASTM D6978 - 05(2019)
Under the conditions of the study
the permeation is acceptable
for the drugs tested for use with
the subject gloves | Pass |
| Human Skin
Sensitization | To demonstrate low
dermatitis potential | Modified Draize-95 Test
Under the conditions of the study,
not a sensitizer. | Pass |
| Endotoxin Study | To demonstrate low
endotoxin levels | Less than 20.0 EU/device | Pass |
| Material Mediated
Pyrogenicity Study | To demonstrate low
pyrogenicity potential | ISO 10993-11:2017
Under the conditions of the study,
has met the material mediated
pyrogenicity requirement | Pass |

11

12

Clinical Summary:

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis potential were tested in accordance with Modified Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510k] Submissions for Testing Skin Sensitization Chemicals in Natural Rubber Products 1999". Both the inner and the outer surfaces of the subject glove were tested. The results showed low dermatitis potential for the human subject tested.

Conclusion

The conclusions drawn from the clinical and non-clinical tests performed demonstrate that the subject device, Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential, is as safe, as effective, and performs as well as or better than the predicate device K190018.