Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes surgical gloves and their material properties and testing, with no mention of AI or ML.

Therapeutic

No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition. Its purpose is protective, not therapeutic.

Diagnostic

No
The device, Gammex PI Hybrid Surgical Gloves, is intended to protect a surgical wound from contamination by being worn by operating room personnel. It is a protective barrier, not a tool used to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product (surgical gloves made of synthetic rubber blend) and describes non-clinical testing related to physical properties and material performance, not software functionality.

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 focuses on the material and construction of the gloves for protection and ease of use.
Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Testing: The testing mentioned (ASTM and ISO standards for physical properties, sterility, chemotherapy permeation) relates to the protective and functional aspects of the gloves, not diagnostic performance.

IVD devices are typically used to test samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device is a physical barrier used during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Gammex PI Hybrid 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.

Product codes

KGO

Device Description

Gammex Pl Hybrid Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic rubber blend of polyisoprene and polychoroprene. A polyurethane polymer coating is applied to the inner surface of the glove to make donning eay. 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 effective for handling 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Summary:
A clinical study was not conducted on the subject or predicate devices.

Technological Characteristics
Gammex PI Hybrid Surgical Gloves, tested for use with chemotherapy drugs, have the following technological characteristics as compared to ASTM or equivalent standards:

Technological Characteristics	Standard/Test/FDA Guidance	Result Summary
Dimensions	ASTM D3577-09	Meets ASTM D3577-09 requirements for length, width and thickness
Length	Minimum 265mm	Average 303mm
Palm Width(size)	(mm)	Average value in mm
5.5	70±6	75
6	76±6	80
6.5	83±6	85
7	89±6	91
7.5	95±6	97
8	102±6	103
8.5	108±6	112
9	114±6	117
Thickness	(mm)	Average value in mm
Finger	Minimum 0.10	0.22
Palm	Minimum 0.10	0.2
Cuff	Minimum 0.10	0.15
Physical Properties	ASTM D3577-09	Meets ASTM D3577-09 requirements for tensile strength and elongation at break before and after accelerated aging
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 10-6 SAL
Biocompatibility:
ISO in vitro cytotoxicity	ISO 10993-5:2009	Under the conditions of the study, the device extract was found to be cytotoxic and therefore the device extracts were evaluated by ISO 10993-11 - Test for systemic toxicity. From the 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

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

Not Found

Predicate Device(s)

K151694

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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 22, 2019

Ansell Healthcare Products, LLC. Don Cronk Sr Manager, QARA / Technical Services 2301 Robb Drive Reno, Nevada 89523

Re: K182948

Trade/Device Name: Gammex PI Hybrid 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: February 21, 2019 Received: February 21, 2019

Dear Don Cronk:

We have reviewed vour 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,

Clarence W. Murray lii III -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

Indications for Use

510(k) Number (if known) K182948

Device Name

Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

Gammex PI Hybrid 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.

Tested chemotherapy drugs are as follows:

Test Chemotherapy drug & Concentration	Minimum Breakthrough Detection Time in Minutes
Bleomycin sulfate (15.0 mg/ml)	>240
Busulfan (6.0 mg/ml)	>240
Carboplatin (10.0 mg/ml)	>240
Carmustine (3.3 mg/ml)	23.6
Cisplatin (1.0 mg/ml)	>240
Cyclophosphamide (20.0 mg/ml)	>240
Cytarabine (100.0 mg/ml)	>240
Dacarbazine (10 mg/ml)	>240
Daunorubicin (5.0 mg/ml)	>240
Docetaxel (10.0 mg/ml)	>240
Doxorubicin Hydrochloride (2.0 mg/ml)	>240
Epirubicin (2.0 mg/ml)	>240
Etoposide (20.0 mg/ml)	>240
Fludarabine (25.0 mg/ml)	>240
Fluorouracil(50.0 mg/ml)	>240
Gemcitabine (Gemzar) (38.0 mg/ml)	>240
Idarubicin (1.0 mg/ml)	>240
Ifosfamide (50.0 mg/ml)	>240
Irinotecan (20.0 mg/ml)	>240
Mechlorethamine HCl(1.0 mg/ml)	>240
Melphalan (5.0 mg/ml)	>240
Methotrexate (25.0 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
Rituximab (10.0 mg/ml)	>240
ThioTEPA (10.0 mg/ml)	36.1
Vincristine Sulfate(1.0 mg/ml)	>240

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 K182948

Submitter

Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 USA

Contact Person:

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

Date Prepared

March 14th 2019

Name of Device

Trade Names:	Gammex PI Hybrid Surgical Gloves Tested 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:	K182948

Legally Marketed Predicate Device

K151694 – Gammex PI Hybrid Surgical Gloves

Device Description

Gammex Pl Hybrid Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic rubber blend of polyisoprene and polychoroprene. A polyurethane polymer coating is applied to the inner surface of the glove to make donning eay. 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 effective for handling chemotherapy agents.

Indication for Use Statement

Gammex PI Hybrid 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 1,2,3)(mins) |
|------------------------- | Bleomycin sulfate (15.0 mg/ml) | Busulfan (6.0 mg/ml) | Carboplatin (10.0 mg/ml) | Carmustine (3.3 mg/ml) | Cisplatin (1.0 mg/ml) | Cyclophosphamide (20.0 mg/ml) | Cytarabine (100.0 mg/ml) | Dacarbazine (10 mg/ml) | Daunorubicin (5.0 mg/ml) | Docetaxel (10.0 mg/ml) | Doxorubicin Hydrochloride | Epirubicin (2.0 mg/ml) | Etoposide (20.0 mg/ml) | Fludarabine (25.0 mg/ml) | Fluorouracil(50.0 mg/ml) | Gemcitabine (Gemzar) (38.0 mg/ml) | Idarubicin (1.0 mg/ml) | Ifosfamide (50.0 mg/ml) | Irinotecan (20.0 mg/ml) | Mechlorethamine HCl(1.0 mg/ml) | Melphalan (5.0 mg/ml) | Methotrexate (25.0 mg/ml) | Mitomycin C (0.5 mg/ml) | Mitoxantrone (2.0 mg/ml) | Oxaliplatin (2.0 mg/ml) | Paclitaxel (Taxol) (6.0 mg/ml) | Rituximab (10.0 mg/ml) | ThioTEPA (10.0 mg/ml) | Vincrinstine Sulfate(1.0 mg/ml) | Vincrinstine Sulfate(1.0 mg/ml) drug & Concentration | Minimum Breakthrough Detection Time (Sample
---------------|-------------------------------------------------------------|
| >240 |
| >240 |
| >240 |
| 23.6(23.8,26.5,23.6) |
| >240 |
| >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 |
| >240 |
| 36.1(36.1,37.0,36.7) |
| >240 |
| >240 |

6

	Predicate Device		Subject Device	Comparison
Trade Name	Gammex PI Hybrid
Surgical Gloves		Gammex PI Hybrid Surgical Gloves Tested for Use with
Chemotherapy Drugs	Different
510(k) Number	K151694		K182948	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	These gloves are
intended to be worn
by operating room
personnel to protect
a surgical wound
from
contamination.		Gammex PI Hybrid 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.

7

8

The subject device is manufactured from synthetic rubber blend of polyisoprene with polyurethane polymer inner coating to aid donning. The predicate device is manufactured from the same formulation. The subject device's materials are functionally equivalent to those of the subject device is identical to the prior cleared version of the device in all regards with the exception of the chemotherapy claims found within the Indications for Use.

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 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.

Non-Clinical Summary:

A clinical study was not conducted on the subject or predicate devices.

Technological Characteristics

Gammex PI Hybrid Surgical Gloves, tested for use with chemotherapy drugs, have the following technological characteristics as compared to ASTM or equivalent standards:

9

Technological Characteristics	Standard/Test/FDA Guidance	Result Summary
Dimensions	ASTM D3577-09	Meets ASTM D3577-09 requirements for length, width and thickness
Length	Minimum 265mm	Average 303mm
Palm Width(size)	(mm)	Average value in mm
5.5	70±6	75
6	76±6	80
6.5	83±6	85
7	89±6	91
7.5	95±6	97
8	102±6	103
8.5	108±6	112
9	114±6	117
Thickness	(mm)	Average value in mm
Finger	Minimum 0.10	0.22
Palm	Minimum 0.10	0.2
Cuff	Minimum 0.10	0.15
Physical Properties	ASTM D3577-09	Meets ASTM D3577-09 requirements for tensile strength and elongation at break
before and after accelerated aging
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 10-6 SAL
Biocompatibility:
ISO in vitro cytotoxicity	ISO 10993-5:2009	Under the conditions of the study, the device extract was found to be cytotoxic and therefore the device extracts were evaluated by ISO 10993-11 - Test for systemic toxicity. From the 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

Conclusion

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