GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)

K231902 · Ansell Healthcare · KGO · Oct 20, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231902
• Device Name: GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
• Applicant: Ansell Healthcare
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Oct 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Sterile, disposable, hand-specific surgical gloves; synthetic polyisoprene and neoprene blend; brown color; beaded cuff. Used by operating room personnel to protect surgical wounds from contamination. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978. Provides barrier protection; does not involve software or algorithms.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D3577 (dimensions, physical properties, freedom from holes, powder residuals), ASTM D6978 (chemotherapy permeation), and ISO 10993 (biocompatibility: irritation, sensitization, systemic toxicity, cytotoxicity). USP <151> testing confirmed non-pyrogenic status.

Technological Characteristics

Synthetic polyisoprene and neoprene blend; polymer coating; sterile (gamma irradiation, 10^-6 SAL); powder-free; hand-specific; beaded cuff. Meets ASTM D3577-19, ASTM D6978-05(2019), and ISO 10993 standards. Brown color.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Tested for use with specific chemotherapy drugs per ASTM D6978. Warning: Do not use with Carmustine or ThioTEPA.

Regulatory Classification

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.

Predicate Devices

• Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (K182948)

Submission Summary (Full Text)

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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.

October 20, 2023

Ansell Healthcare Carson Delaloye Senior Administrator Quality 2301 Robb Drive Reno, Nevada 89523

## Re: K231902

Trade/Device Name: GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, OPJ Dated: September 21, 2023 Received: September 21, 2023

Dear Carson Delaloye:

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 (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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Image /page/2/Picture/3 description: The image shows the text "Bifeng Qian -S" in a large, sans-serif font. The text is black and is set against a white background. The words are arranged horizontally, with "Bifeng" and "Qian" being the most prominent. The "-S" is smaller and slightly offset to the right.

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

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# Indications for Use

510(k) Number (if known) K231902

#### Device Name

GAMMEX PI Hybrid Micro (340002055): GAMMEX PI Hybrid Micro (340002060): GAMMEX PI Hybrid Micro (340002065): GAMMEX PI Hybrid Micro (340002070): GAMMEX PI Hybrid Micro (340002075): GAMMEX PI Hybrid Micro (340002080): GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)

#### Indications for Use (Describe)

Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test chemotherapy drug and concentration Minimum breakthrough detection time in minutes Bleomycin (15.0 mg/ml) >240 Busulfan (6.0 mg/ml) >240 Carboplatin (10.0 mg/ml) >240 Carmustine (3.3 mg/ml) 24.1 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Cytarabine HCl (100.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Daunorubicin HCl (5.0 mg/ml) >240 Docetaxel (10.0 mg/ml) >240 Doxorubicin HCl (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 (38.0 mg/ml) >240 Idarubicin (1.0 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Irinotecan (20.0 mg/ml) >240 Mechlorethamine HCI (1.0 mg/ml) >240 Melphalan (5.0mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0mg/ml) >240 Oxaliplatin (2.0 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Rituximab (10.0 mg/ml) >240 ThioTEPA (10.0 mg/ml) 26.0 Vincristine Sulfate (1.0 mg/ml) >240 Warning: Do not use with Carmustine or ThioTEPA Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### 510KSummary

### 510(k) Number:

K231902

### Submitter:

Ansell Healthcare 2301 Robb Drive Reno, NV 89523

### Contact Person(s):

Carson Delaloye Senior Coordinator, Regulatory Affairs Phone: [phone] Email: [e-mail]

#### Date Prepared

October 16, 2023

#### Name of Device

| Trade Names: | GAMMEX PI Hybrid Micro (340002055); |
|----------------------------|-------------------------------------|
| | GAMMEX PI Hybrid Micro (340002060); |
| | GAMMEX PI Hybrid Micro (340002065); |
| | GAMMEX PI Hybrid Micro (340002070); |
| | GAMMEX PI Hybrid Micro (340002075); |
| | GAMMEX PI Hybrid Micro (340002080); |
| | GAMMEX PI Hybrid Micro (340002085); |
| | GAMMEX PI Hybrid Micro (340002090) |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Non-Powdered Surgeon's Glove |
| Classification Regulation: | 21 CFR 878.4460 |
| Device Class: | I |
| Product Code: | KGO, OPJ |
| Classification Panel: | General and Plastic Surgery |

#### Legally Marketed Predicate Device

| K182948 | |
|----------------------|-------------------------------------------------------------------------|
| Trade Name: | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Non-Powdered Surgeon's Glove |

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| Classification Regulation: | 21 CFR 878.4460 |
|----------------------------|-----------------------------|
| Device Class: | I |
| Product Code: | KGO |
| Classification Panel: | General and Plastic Surgery |

### Device Description

Gammex PI Hybrid Micro Surgical Gloves are sterile and disposable devices. The gloves are made of a synthetic rubber polyisoprene and neoprene blend. Ansell has performed independent laboratory testing to support use with Chemotherapy Drugs and Non-Pyrogenic claims. The glove has a shelf life of 3 years, is brown in color and comes in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Each size is assigned with a model number.

#### Indication for Use Statement

Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Test chemotherapy drug and concentration | Minimum breakthrough<br>detection time in minutes |
|------------------------------------------|---------------------------------------------------|
| Bleomycin (15.0 mg/ml) | >240 |
| Busulfan (6.0 mg/ml) | >240 |
| Carboplatin (10.0 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 24.1 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Cytarabine HCl (100.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Daunorubicin HCl (5.0 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin HCl (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 (38.0 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0 mg/ml) | >240 |
| Mechlorethamine HCI (1.0 mg/ml) | >240 |
| Melphalan (5.0mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |

Tested chemotherapy drugs are as follows:

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| Mitomycin C (0.5 mg/ml) | >240 |
|---------------------------------|------|
| Mitoxantrone (2.0mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Rituximab (10.0 mg/ml) | >240 |
| ThioTEPA (10.0 mg/ml) | 26.0 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |

Warning: Do not use with Carmustine or ThioTEPA

### Technological Characteristics:

## Technological Characteristics Comparison Table for Predicate Device

| | Predicate Device | Proposed Subject Device | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | Gammex PI Hybrid Surgical Gloves Tested for<br>Use with Chemotherapy Drugs | GAMMEX PI Hybrid Micro (340002055);<br>GAMMEX PI Hybrid Micro (340002060);<br>GAMMEX PI Hybrid Micro (340002065);<br>GAMMEX PI Hybrid Micro (340002070);<br>GAMMEX PI Hybrid Micro (340002075);<br>GAMMEX PI Hybrid Micro (340002080);<br>GAMMEX PI Hybrid Micro (340002085);<br>GAMMEX PI Hybrid Micro (340002090) | Different -<br>Trade Name<br>o The names are<br>different to indicate<br>which of the devices is<br>the smaller version. This<br>does not affect safety or<br>efficacy as the difference<br>is to inform the end user. |
| 510k Number | K182948 | K231902 | Different -New 510(k) |
| Product<br>Owner | Ansell Healthcare | Ansell Healthcare | Same |
| Product Code | KGO | KGO, OPJ | Different -OPJ product code<br>added for chemo |
| Regulation<br>Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Regulatory<br>Class | I | I | Same |
| Regulation<br>Name | Non-powdered Surgeon's Gloves | Non-powdered Surgeon's glove | Same |
| Indications for<br>Use | Gammex PI Hybrid Surgical Gloves are<br>intended to be worn by operating room<br>personnel to protect a surgical wound from<br>contamination. These gloves were tested for<br>use with Chemotherapy Drugs as per ASTM<br>D6978-05 Standard Practice for Assessment of<br>Medical Gloves to Permeation by<br>Chemotherapy Drugs.<br>Tested chemotherapy drugs are as follows:<br>Test Chemotherapy drug & Concentration<br>Minimum Breakthrough Detection Time in<br>Minutes<br>Bleomycin sulfate (15.0 mg/ml) >240 | Gammex PI Hybrid Micro Surgical Gloves are sterile,<br>non-pyrogenic, are intended to be worn by<br>operating room personnel to protect a surgical<br>wound from contamination and have a shelf life of 3<br>years. These gloves were tested for use with<br>Chemotherapy Drugs as per ASTM D6978 Standard<br>Practice for Assessment of Medical Gloves to<br>Permeation by Chemotherapy Drugs.<br>Tested chemotherapy drugs are as follows:<br>Test Chemotherapy drug & concentration Minimum<br>Breakthrough detection time in minutes<br>Bleomycin sulfate (15.0 mg/ml) >240<br>Busulfan (6.0 mg/ml) >240 | Different<br>Itemized List of<br>Differences Between<br>Predicate and Proposed:<br>• Indications for Use<br>o The indications for use<br>differ as the proposed<br>device carries non-<br>pyrogenic claims. The<br>permeation times also<br>differ for Carmustine and<br>ThioTEPA. |

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| | Busulfan (6.0 mg/ml) >240 | Carboplatin (10.0 mg/ml) >240 | Carboplatin (10.0 mg/ml) >240 | Carmustine (3.3 mg/ml) 24.1 | Same | |
|------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------|--|
| | Carboplatin (10.0 mg/ml) >240 | Carmustine (3.3 mg/ml) 23.6 | Carmustine (3.3 mg/ml) 24.1 | Cisplatin (1.0 mg/ml) >240 | | |
| | Carmustine (3.3 mg/ml) 23.6 | Cisplatin (1.0 mg/ml) >240 | Cisplatin (1.0 mg/ml) >240 | Cyclophosphamide (20.0 mg/ml) >240 | | |
| | Cisplatin (1.0 mg/ml) >240 | Cyclophosphamide (20.0 mg/ml) >240 | Cyclophosphamide (20.0 mg/ml) >240 | Cytarbine (100.0 mg/ml) >240 | | |
| | Cyclophosphamide (20.0 mg/ml) >240 | Cytarabine (100.0 mg/ml) >240 | Cytarbine (100.0 mg/ml) >240 | Dacarbazine (10 mg/ml) >240 | | |
| | Cytarabine (100.0 mg/ml) >240 | Dacarbazine (10 mg/ml) >240 | Dacarbazine (10 mg/ml) >240 | Daunorubicin (5.0 mg/ml) >240 | | |
| | Dacarbazine (10 mg/ml) >240 | Daunorubicin (5.0 mg/ml) >240 | Daunorubicin (5.0 mg/ml) >240 | Docetaxel (10.0 mg/ml) >240 | | |
| | Daunorubicin (5.0 mg/ml) >240 | Docetaxel (10.0 mg/ml) >240 | Docetaxel (10.0 mg/ml) >240 | Doxorubicin Hydrochloride (2.0 mg/ml) >240 | | |
| | Docetaxel (10.0 mg/ml) >240 | Doxorubicin Hydrochloride (2.0 mg/ml) >240 | Doxorubicin Hydrochloride (2.0 mg/ml) >240 | Epirubicin (2.0 mg/ml) >240 | | |
| | Doxorubicin Hydrochloride (2.0 mg/ml) >240 | Epirubicin (2.0 mg/ml) >240 | Epirubicin (2.0 mg/ml) >240 | Etoposide (20.0 mg/ml) >240 | | |
| | Epirubicin (2.0 mg/ml) >240 | Etoposide (20.0 mg/ml) >240 | Etoposide (20.0 mg/ml) >240 | Fludarabine (25.0 mg/ml) >240 | | |
| | Etoposide (20.0 mg/ml) >240 | Fludarabine (25.0 mg/ml) >240 | Fludarabine (25.0 mg/ml) >240 | Fluorouracil (50.0 mg/ml) >240 | | |
| | Fludarabine (25.0 mg/ml) >240 | Fluorouracil(50.0 mg/ml) >240 | Fluorouracil (50.0 mg/ml) >240 | Gemcitabine (Gemzar) (38.0 mg/ml) >240 | | |
| | Fluorouracil(50.0 mg/ml) >240 | Gemcitabine (Gemzar) (38.0 mg/ml) >240 | Gemcitabine (Gemzar) (38.0 mg/ml) >240 | Idarubicin (1.0 mg/ml) >240 | | |
| | Gemcitabine (Gemzar) (38.0 mg/ml) >240 | Idarubicin (1.0 mg/ml) >240 | Idarubicin (1.0 mg/ml) >240 | Ifosfamide (50.0 mg/ml) >240 | | |
| | Idarubicin (1.0 mg/ml) >240 | Ifosfamide (50.0 mg/ml) >240 | Ifosfamide (50.0 mg/ml) >240 | Irinotecan (20.0 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 | | |
| | Irinotecan (20.0 mg/ml) >240 | Mechlorethamine HCl(1.0 mg/ml) >240 | Mechlorethamine HCI (1.0 mg/ml) >240 | Melphalan (5.0 mg/ml) >240 | | |
| | Mechlorethamine HCl(1.0 mg/ml) >240 | Melphalan (5.0 mg/ml) >240 | Melphalan (5.0 mg/ml) >240 | Methotrexate (25.0 mg/ml >240 | | |
| | Melphalan (5.0 mg/ml) >240 | Methotrexate (25.0 mg/ml) >240 | Methotrexate (25.0 mg/ml) >240 | Mitomycin C (0.5 mg/ml) >240 | | |
| | Methotrexate (25.0 mg/ml) >240 | Mitomycin C (0.5 mg/ml) >240 | Mitomycin C (0.5 mg/ml) >240 | Mitoxantrone (2.0 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 | | |
| | 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 | | |
| | Oxaliplatin (2.0 mg/ml) >240 | Paclitaxel (Taxol) (6.0 mg/ml) >240 | Paclitaxel (Taxol) (6.0 mg/ml) >240 | Rituximab (10.0 mg/ml) >240 | | |
| | Paclitaxel (Taxol) (6.0 mg/ml) >240 | Rituximab (10.0 mg/ml) >240 | Rituximab (10.0 mg/ml) >240 | ThioTEPA (10.0 mg/ml) 26.0 | | |
| | Rituximab (10.0 mg/ml) >240 | ThioTEPA (10.0 mg/ml) 36.1 | ThioTEPA (10.0 mg/ml) 26.0 | Vincristine Sulfate (1.0 mg/ml) >240 | | |
| | ThioTEPA (10.0 mg/ml) 36.1 | Vincrinstine Sulfate(1.0 mg/ml) >240 | Vincristine Sulfate (1.0 mg/ml) >240 | Warning: Do not use with Carmustine or ThioTEPA | | |
| | Vincrinstine Sulfate(1.0 mg/ml) >240 | | Warning: Do not use with Carmustine or ThioTEPA | | | |
| Material<br>Composition | Synthetic polyisoprene rubber | | Synthetic polyisoprene rubber | | Same | |
| Coating | Polymer Coating | | Polymer Coating | | Same | |
| Design | Single use | | Single use | | Same | |
| | Powder-free | | Powder-free | | Same | |
| | Hand Specific | | Hand Specific | | Same | |
| | Beaded cuff | | Beaded cuff | | Same | |
| | Natural | | Brown | | Different - Changed<br>Color | |
| Color | | | | | | |
| Labeling | Surgeon's Gloves | | Surgeon's Gloves | | Same | |
| Shelf Life | 3 Years | | 3 Years | | Same | |
| Performance<br>a. Dimensions | Meets ASTM D3577-19 (2015) requirements | | Meets ASTM D3577-19 requirements | | Same | |
| b. Physical<br>Properties | Meets ASTM D3577-19 (2015) requirements | | Meets ASTM D3577-19 requirements | | Same | |
| | | | Meets ASTM D3577-19 (2015) | | | |
| c. Freedom from | Meets ASTM D3577-19 (2015) | | | | Same | |
| holes | AQL Meets CFR 800.20 Requirements | | AQL Meets CFR 800.20 Requirements | | | |
| d. Powder | Meet applicable definition for powder free per | | Meet applicable definition for powder free per | | Same | |
| Residual | ASTM D3577-19; ≤ 2mg per glove | | ASTM D3577-19; ≤ 2mg per glove | | | |
| e. Sterility | Sterile | | Sterile | | Same | |
| Bio-<br>compatibility<br>Skin Irritation | Passes Primary Skin Irritation test per ISO<br>10993-10, Biological Evaluation of medical | | Passes Primary Skin Irritation test per ISO 10993-10,<br>Biological Evaluation of medical devices, Part 10:<br>Test for irritation and skin sensitization | | Same | |

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| Bio-<br>compatibility<br>Sensitization | Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization | Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization | Same |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Bio-<br>compatibility<br>Acute Systemic<br>Toxicity | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity | Same |
| Bio-<br>compatibility<br>Cytotoxicity | 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 | 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 | Same |
| Non-pyrogenic | Not reported | Passes Material Mediated Pyrogenicity Test per USP <151>. Under the conditions of the study, non-pyrogenic.<br>Less than 20.0 EU/device. Under the conditions of the study, low endotoxin levels. | Different |
| Sterilization<br>Method | Gamma Irradiation | Gamma Irradiation | Same |
| Sterilization<br>Information | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL. | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL. | Same |
| Prescription or<br>Over The<br>Counter | Over the Counter | Over the Counter | Same |

# ltemized List of Differences Between Predicate and Proposed:

- Trade Name
The names are different to indicate which of the devices is the smaller version. This does not affect safety or efficacy as the difference is to inform the end user.

- . Indications For Use The indications for use differ as the proposed device carries non-pyrogenic claims. The permeation times also differ for Carmustine and ThioTEPA.
- . Color

The color is listed as different for the devices. Brown pigmentation was added to the Proposed Subject device.

- Non-pyrogenic
The proposed device has demonstrated low endotoxin levels and did not elicit a pyrogenic response in testing. Testing was not reported for the predicate device.

# Non-Clinical Testing

Gammex® Pl Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs has the following technological characteristics as compared to ASTM or equivalent standards:

{10}------------------------------------------------

| Results | Title of Test | Purpose of Test | Acceptance Criteria |
|---------|------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PASS | ASTM<br>D3767-03 | Dimensions | Acceptance criteria in accordance with ASTM D3577-19: Standard<br>Specification for Rubber Surgical Gloves |
| PASS | ASTM<br>D3577-19 | Physical Properties | Acceptance criteria for tensile strength, ultimate elongation and stress<br>at 500% elongation before and after accelerated aging for synthetic<br>surgical gloves per ASTM D3577-19: Standard Specification for Rubber<br>Surgical Gloves |
| PASS | ASTM<br>D5151-19 | Freedom from holes | Acceptance criteria in accordance with ASTM D3577-19: Standard<br>Specification for Rubber Surgical Gloves with AQL requirements of 1.5 |
| PASS | ASTM D6124 | Powder-Free | Meets applicable acceptance criteria for powder free ≤ 2mg per glove<br>per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves |
| PASS | ANSI/AAMI/ ISO<br>11137-<br>1:2006 | Sterility | Meets acceptance criteria requirement of 10-6 SAL per ISO 11137-1:<br>Sterilization for Health Care Products - Radiation - Part 1: Requirements<br>for Development, Validation and Routine Control of A Sterilization<br>Process For Medical Devices |
| PASS | ASTM<br>D6978- 05(2019) | Chemotherapy Drug<br>Permeation Test | Acceptance Criteria in accordance with ASTM D6978-05(2019):<br>Standard Practice for Assessment of Resistance of Medical Gloves to<br>Permeation by Chemotherapy Drugs.<br>*Please note that the following drugs have extremely low permeation<br>times: Carmustine (24.1 min) and Thiotepa (26.0 min) |
| FAIL | ISO 10993-5 | ISO in vitro Cytotoxicity<br>Study | Surfaces at undiluted were found to be cytotoxic (grade 4) to L-929<br>cells and non-cytotoxic with grade 0 at 1:2, 1:4, 1:8, 1:16, 1:32 and 1;64<br>dilutions. Acceptance criteria in accordance with ISO 10993-5:<br>Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro<br>Cytotoxicity, 2009. |
| PASS | ISO 10993-<br>10:2010 | ISO Skin<br>Irritation Study | Passes Primary Skin Irritation test per ISO 10993-10, Biological<br>Evaluation Of Medical Devices, Part 10: Test for Irritation and Skin<br>Sensitization. Under the conditions of the study, not an irritant. |
| PASS | ISO 10993-<br>10:2010 | ISO<br>Maximization<br>Sensitization Study | Passes Dermal Sensitization test per ISO 10993-10, Biological<br>Evaluation of medical devices, Part 10: Test for Irritation and Skin<br>Sensitization. Under the conditions of the study, not a sensitizer |
| PASS | ISO 10993-<br>11:2017 | ISO Acute Systemic<br>Toxicity Study - ISO<br>10993-11:2017 | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological<br>Evaluation of medical devices, Part 11: Test for Systemic Toxicity.<br>Under the conditions of the study, there was no mortality or evidence<br>of acute systemic toxicity |
| PASS | USP <151> | Material Mediated<br>Pyrogenicity Study -<br>USP <151> | Passes Material Mediated Pyrogenicity Test per USP <151>. Under the<br>conditions of the study, non-pyrogenic. |
| PASS | Endotoxin Study | Demonstrate low<br>endotoxin levels | Less than 20.0 EU/device |

### Clinical Studies

A clinical study was not conducted on the subject device.

#### Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, GAMMEX Pl Hybrid Micro, is as safe, as effective, and performs as well as or better than the legally marketed device K182948.