Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

K230121 · Careglove Global Sdn. Bhd. · LZA · May 15, 2023 · General Hospital

Device Facts

• Record ID: K230121
• Device Name: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
• Applicant: Careglove Global Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: May 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, powder-free nitrile examination gloves (blue and black). Manufactured from synthetic rubber latex via on-line polymer coating and chlorination for tack-free surface. Used by healthcare professionals in clinical settings to provide a barrier against contamination between patient and examiner. Tested per ASTM D6978-05 for permeation resistance against specific chemotherapy drugs and fentanyl citrate. Output is a physical barrier; healthcare providers use the gloves during patient examinations or handling of hazardous drugs to reduce exposure risk. Warning: Do not use with Carmustine or Thiotepa due to low permeation times.

Clinical Evidence

No clinical data. Bench testing only. Testing included ASTM D6319-19 (dimensions, physical properties), ASTM D5151-19 (freedom from holes), ASTM D6124-06 (residual powder), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing per ISO 10993-5, -10, and -11 demonstrated the device is not a primary skin irritant or sensitizer, showed no acute systemic toxicity, and exhibited acceptable cytotoxicity profiles.

Technological Characteristics

Material: Nitrile synthetic rubber latex. Design: Powder-free, non-sterile, ambidextrous, beaded cuff. Surface treatment: On-line polymer coating and chlorination. Standards: ASTM D6319-19, ASTM D6978-05, ISO 10993. Dimensions: Length 220-230mm min, thickness 0.05mm min. Connectivity: None. Sterilization: Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs and fentanyl citrate.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K213408)

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

May 15, 2023

Careglove Global SDN. BHD. Lim Kwee Shyan Managing Director Lot 17479, Lrg Senawang 3/2, Off JIn Senawang 3 Senawang Ind. Estate Seremban, Negeri Sembilan 70450 Malaysia

Re: K230121

Trade/Device Name: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: April 10, 2023 Received: April 13, 2023

Dear Lim Shyan:

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.

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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/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 ([e-mail]) or phone [phone] 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

#### 510(k) Number (if known) K230121

#### Device Name

NTRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE)

## Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time (Minutes) |
|----------------------------|---------------|-----------------------------------------------|
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 |
| Cisplatin | 1.0 mg/ml | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min |
| Doxorubicin HCl | 2.0 mg/ml | >240 min |
| Etoposide | 20.0 mg/ml | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min |
| *Thiotepa | 10.0 mg/ml | 43.9 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min |
| Fentanyl Citrate Injection | 100mcg/2ml | >240 min |

*Please note that following drugs have extremely low permeation times: Carmustine (BCNU) 3.3mg/ml 22.6 minutes Thiotepa 10.0mg/ml 43.9 minutes

Warning: Do not use these gloves with Carmustine or Thiotepa.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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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 [e-mail]

"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."

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

# 510(k) Number (if known) K230121

#### Device Name

NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLACK)

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time (Minutes) |
|----------------------------|---------------|-----------------------------------------------|
| *Carmustine (BCNU) | 3.3 mg/ml | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min |
| Doxorubicin HCl | 2.0 mg/ml | >240 min |
| Etoposide | 20.0 mg/ml | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min |
| *Thiotepa | 10.0 mg/ml | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min |
| Fentanyl Citrate Injection | 100mcg/2ml | >240 min |

* Please note that following drugs have extremely low permeation times: Carmustine (BCNU) 3.3mg/ml 21.8 minutes Thiotepa 10.0mg/ml 17.7 minutes

Warning: Do not use these gloves 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.

{5}------------------------------------------------

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 [e-mail]

"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."

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## 510(K) SUMMARY

## K230121

| Applicant Name | CAREGLOVE GLOBAL SDN BHD | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------|
| Location | Lot 17479, Lorong Senawang 2/3<br>Off Jalan Senawang 3,<br>Senawang Industrial Estate,<br>70450 Seremban,<br>Negeri Sembilan Darul Khusus,<br>Malaysia. | | |
| Phone No: | (60) 6 6782377 | Fax No: | (60) 6 6785377 |
| Contact Person: | Lim Kwee Shyan | | |
| Summary Preparation Date: | 15th May 2023 | | |

## Device Information

| Trade Name: | NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE<br>WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK) |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Common Name: | POWDER FREE NITRILE EXAMINATION GLOVES |
| Classification Name: | Non-Powdered Patient Examination Gloves |
| Product Code: | LZA, LZC, QDO, OPJ |
| Regulation: | 21CFR:880.6250 |

## Predicate Device

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, 510(K) number K213408 product code LZA, LZC, QDO.

## Device Description

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powderfree variation of the class I Nitrile Patient Examination Gloves which is coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs and Fentanyl Citrate as below:

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| Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|------------------------------------------------------------------------|---------------|-----------------------------------------------|----------|
| | | Blue | Black |
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min |
| Etoposide | 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min |
| *Please note that following drugs have extremely low permeation times: | | | |

1. Carmustine (BCNU)

2. Thio Tepa

Warning: Do not use with Carmustine and Thiotepa

#### Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drugs | Concentration | Minimum Breakthrough Detection Time (minutes) | |
|------------------------------------------------------------------------|---------------|-----------------------------------------------|----------|
| | | Blue | Black |
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min |
| Etoposide | 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min |
| *Please note that following drugs have extremely low permeation times: | | | |

rugs have extremely low permeation times: owing ul

1. Carmustine (BCNU)

2. Thio Tepa

Warning: Do not use with Carmustine and Thiotepa

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# Summary of The Technological Characteristic

The Nitrile Examination Gloves Powder Free – Blue & Black, are summarized with the following technological characteristic compared to ASTM D6319 or equivalent standards.

| Characteristic | Standard | Subject Device<br>K230121 | Predicate Device<br>K213408 | Remarks |
|----------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | - | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Same |
| Intended Use | - | Intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner | Intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner | Same |
| Design | - | Powder Free, Non-Sterile,<br>Ambidextrous, Beaded Cuff | Powder Free, Non-Sterile,<br>Ambidextrous, Beaded Cuff | Same |
| Indications for<br>Use | - | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with Chemotherapy<br>Drugs and Fentanyl Citrate<br>as per ASTM D6978-05<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs. | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with Chemotherapy<br>Drugs and Fentanyl Citrate<br>as per ASTM D6978-05<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs. | Same |
| Construction | - | Ambidextrous, Polymer<br>Coated or Chlorinated,<br>Powder Free Nitrile | Ambidextrous, Polymer<br>Coated or Chlorinated,<br>Powder Free Nitrile | Same |
| Color Description | - | Blue & Black | Blue | Different |
| Material | - | Nitrile | Nitrile | Similar |
| Single Use | - | Yes | Yes | Same |
| Packaging | - | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Same |
| Chemo Drugs<br>Claim | - | Chemo Drugs & Fentanyl<br>Citrate claim | Chemo Drugs & Fentanyl<br>Citrate claim | Same |
| Sterility | - | Non-Sterile | Non-Sterile | Same |
| Dimension | | | | |
| Length<br>XS, S,<br>M, L, XL | ASTM D6319-19 | Meet 220mm min<br>Meet 230mm min | Minimum 240mm | Similar |
| Thickness (palm),<br>Thickness (finger), | | Meet 0.05mm min<br>Meet 0.05mm min | 0.06 - 0.09mm<br>0.07 - 0.10mm | Similar |
| Width | | XS: Meet $70 \pm 10$ mm<br>S: Meet $80 \pm 10$ mm<br>M: Meet $95 \pm 10$ mm<br>L: Meet $110 \pm 10$ mm<br>XL: Meet $120 \pm 10$ mm | 70 - 75 mm<br>80 - 86 mm<br>93 - 97 mm<br>102 - 106 mm<br>114 - 116 mm | Similar |
| Characteristic | Standard | Subject Device<br>K230121 | Predicate Device<br>K213408 | Remarks |
| Physical Properties | | | | |
| (Before Ageing)<br>i) Tensile Strength<br>(MPa)<br>ii) Ultimate<br>Elongation (%) | ASTM D6319-19 | Meet 14MPa min.<br>Meet 500% min | Meet 14MPa min.<br>Meet 500% min | Similar |
| (After Aging)<br>i) Tensile Strength<br>(MPa)<br>ii) Ultimate<br>Elongation (%)<br>Water Leak Test,<br>1000 ml | ASTM D6319-19 | Meets 14MPa min<br>Meet 400% min. | Meets 14MPa min<br>Meet 400% min. | Similar |
| Before Aging, AQL | ASTM D6319-19<br>ASTM D5151-19 | Passes at AQL 1.5 | Passes at AQL 1.5 | Similar |
| Powder Free<br>Residue | ASTM D6319-19<br>ASTM D6124-06 | Meet 2mg/glove max. | Meet 2mg/glove max | Similar |
| Powder Free<br>Residue, mg/glove | | | | |
| Biocompatibility<br>Test | | | | |
| i) Primary Skin<br>Irritation Test | ISO 10993-10 | Passes<br>Conclusion: Under the<br>conditions of this study the<br>test material did not cause an<br>irritant response | Passes (Not a primary skin<br>irritant)<br>There was no erythema or<br>oedema noted on test site<br>after (1±0.1), (24±2), (48±2)<br>and (72±2) hours. The primary<br>Irritation Index (PII) was "0".<br>Also, no mortality after 72<br>hours. The gloves are<br>considered negligible. | Similar |
| ii)Skin Sensitization<br>Test | ISO 10993-10 | Passes<br>Conclusion: Under the<br>conditions of this study, the<br>test material did not produce a<br>skin sensitization effect | Passes (Not a contact<br>sensitizer)<br>There was no positive allergic<br>reaction observed during the<br>challenge phase (at 0, 24<br>hours and 48 hours) in<br>animals treated with the test<br>material and negative control.<br>Conclusion: Under the<br>conditions of this study, the<br>test material did not produce a<br>skin sensitization effect. | Similar |
| iii) In Vitro<br>Cytotoxicity Test | ISO 10993-<br>5:2009 | Conclusion: Under condition<br>of this study, test material<br>exhibited moderate<br>cytotoxicity reactivity at 6.0<br>cm²/mL extract concentrations<br>and no cytotoxicity reactivity<br>at the 3.0 cm²/mL extract<br>concentrations of the test. | Exhibit severe cytotoxicity<br>reactivity at 100%, 50%, and<br>25% extract concentration. No<br>cytotoxicity reactivity at<br>12.5%, 6.25% and 3.125%<br>extract concentrations. | Similar |
| iv) Acute Systemic<br>Toxicity | ISO 10993-11 | Conclusion: Under condition.<br>of this study, the test material<br>showed no adverse biological<br>reaction after administration of<br>the sample's extract on the | Passes (no adverse biological<br>reaction) No mortality was<br>observed (72±2) hours. | Similar |
| Characteristic | Standard | Subject Device<br>K230121 | Predicate Device<br>K213408 | Remarks |
| | | rats during the period of the<br>study. | | |

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# Summary of Non-Clinical Testing

Following is a table showing the actual measured parameters of the gloves (e.g length, thickness, physical properties, etc.) as compared to ASTM, EN and ISO. All data meets the standard reference requirement.

| Test | Method | Acceptance Criteria | Result | | | | |
|-----------------------------------|--------------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Freedom From<br>Holes | ASTM<br>D6319-19<br>ASTM<br>D5151-19 | Meet requirement inspection level G-1, AQL 2.5 | Pass | | | | |
| Dimension | ASTM<br>D6319-19 | Size | Pass | | | | |
| | | XSmall | | | | | |
| | | Small | | | | | |
| | | Medium | | | | | |
| | | Large | | | | | |
| | | XLarge | | | | | |
| | | Length, min. mm | 220 | | | | |
| | | | 230 | | | | |
| | | Thickness, min. mm | 0.05 | | | | |
| | | Width, ± 10 mm | 70 | | | | |
| | | | 80 | | | | |
| | | | 95 | | | | |
| | | | 110 | | | | |
| | | | 120 | | | | |
| Physical<br>properties | ASTM<br>D6319-19 | | Pass | | | | |
| | | Before Aging | | | | | |
| | | After Accelerated Aging | | | | | |
| | | Tensile<br>Strength | | | | | |
| | | Ultimate<br>Elongation | | | | | |
| | | Tensile<br>Strength | | | | | |
| | | Ultimate<br>Elongation | | | | | |
| | | 14 MPa min. | 500% min. | | | | |
| | | 14 MPa min. | 400 % min. | | | | |
| Residual<br>Powder Content | ASTM<br>D6319-19<br>ASTM<br>D6124-06 | Not more than 2 mg per glove | Pass | | | | |
| Biocompatibility | | | | | | | |
| i) Primary Skin<br>Irritation | ISO 10993-<br>10 | Not a primary skin irritant | Pass | | | | |
| ii) Skin<br>Sensitization | ISO 10993-<br>10 | Not a contact sensitizer | Pass | | | | |
| iii) In Vitro<br>Cytotoxicity | ISO 10993-<br>5:2009 | No adverse biological reaction | Moderate cytotoxicity<br>reactivity at 6.0 cm²/mL<br>and no reactivity at 3.0<br>cm²/mL extract<br>concentrations | | | | |
| iv) Acute<br>Systemic<br>Toxicity | ISO 10993-<br>11 | No adverse biological reaction | Pass | | | | |
| Chemotherapy<br>Drug | Concentration | Minimum Breakthrough Detection Time<br>(minutes) | Remark | | | | |

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| | | Proposed Device | | Predicate Device | |
|-------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------|----------|---------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | Blue | Black | Blue | |
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 | 22.5 | Different |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Cyclophosphamide<br>(Cytoxan) | 20.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Etoposide | 20.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min | >240 min | Same |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min | >240 min | Same |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 | 36.1 | Different |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min | >240 min | Same |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min | >240 min | Same |
| Warning | | Please note that following drugs have extremely low permeation times:<br>1. Carmustine (BCNU) (3.3 mg/ml) 2. Thio Tepa (10 mg/ml) | | *Please note that following drugs have extremely low permeation times:<br>1. Carmustine (BCNU) (3.3 mg/ml)<br>2. Thio Tepa (10 mg/ml) | Similar |

## Summary of Clinical Testing

Not applicable.

# CONCLUSIONS

The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K213408, Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.