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

• K Number: K230121
• Device Name: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
• Manufacturer: Careglove Global SDN. BHD.
• Date Cleared: 2023-05-15 ( 118 days)
• Product Code: LZA LZC OPJ QDO
• Regulation Number: 880.6250

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 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.

Predicate Devices

K213408

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of a patient examination glove, with no mention of AI or ML technology.

Therapeutic

No.
The device, a patient examination glove, is intended for medical purposes to prevent contamination, not to treat or cure a disease or condition.

Diagnostic

No
The device is a patient examination glove, which is intended to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical glove made of synthetic rubber latex, not software. The description details its material, manufacturing process, sizes, and physical properties.

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 clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
• Device Description: The description focuses on the physical properties and materials of the glove, not on any components or processes related to analyzing biological samples.
• Performance Studies and Key Metrics: The performance studies and key metrics listed relate to the physical integrity, barrier properties (especially against chemotherapy drugs and fentanyl), and biocompatibility of the glove. These are relevant to a protective barrier device, not an IVD.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other characteristics typically associated with IVD devices.

In summary, the device is a medical glove intended for protection during patient examination, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Warning: Do not use these gloves with Carmustine or Thiotepa.

Product codes

LZA, LZC, QDO, OPJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purposes)

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)

Summary of Non-Clinical Testing:

• Freedom From Holes: ASTM D6319-19, ASTM D5151-19, Meet requirement inspection level G-1, AQL 2.5, Pass.
• Dimension: ASTM D6319-19, Size (XSmall, Small, Medium, Large, XLarge), Length: min. 220 mm (for XSmall), min. 230 mm (for S, M, L, XL), Thickness (min. mm): 0.05, Width (± 10 mm): 70 (XS), 80 (S), 95 (M), 110 (L), 120 (XL). All Pass.
• Physical properties: ASTM D6319-19, Before Aging (Tensile Strength: 14 MPa min., Ultimate Elongation: 500% min.), After Accelerated Aging (Tensile Strength: 14 MPa min., Ultimate Elongation: 400% min.). All Pass.
• Residual Powder Content: ASTM D6319-19, ASTM D6124-06, Not more than 2 mg per glove, Pass.
• Biocompatibility:
  • i) Primary Skin Irritation: ISO 10993-10, Not a primary skin irritant, Pass.
  • ii) Skin Sensitization: ISO 10993-10, Not a contact sensitizer, Pass.
  • iii) In Vitro Cytotoxicity: ISO 10993-5:2009, No adverse biological reaction, Moderate cytotoxicity reactivity at 6.0 cm²/mL and no reactivity at 3.0 cm²/mL extract concentrations.
  • iv) Acute Systemic Toxicity: ISO 10993-11, No adverse biological reaction, Pass.
• Chemotherapy Drug Permeation and Fentanyl Citrate Permeation (Minimum Breakthrough Detection Time in minutes):
  • Carmustine (BCNU) (3.3 mg/ml): Blue: 22.6, Black: 21.8
  • Cisplatin (1.0 mg/ml): Blue: >240, Black: >240
  • Cyclophosphamide (Cytoxan) (20.0 mg/ml): Blue: >240, Black: >240
  • Dacarbazine (10.0 mg/ml): Blue: >240, Black: >240
  • Doxorubicin HCL (2.0 mg/ml): Blue: >240, Black: >240
  • Etoposide (20.0 mg/ml): Blue: >240, Black: >240
  • Fluorouracil (50.0 mg/ml): Blue: >240, Black: >240
  • Ifosfamide (50.0 mg/ml): Blue: >240, Black: >240
  • Mitoxantrone (2 mg/ml): Blue: >240, Black: >240
  • Paclitaxel (6.0 mg/ml): Blue: >240, Black: >240
  • Thio Tepa (10.0 mg/ml): Blue: 43.9, Black: 17.7
  • Vincristine Sulfate (1.0 mg/ml): Blue: >240, Black: >240
  • Fentanyl Citrate (100mcg/2ml): Blue: >240, Black: >240
    All data meets the standard reference requirement.

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

Not Found. Values for minimum breakthrough detection time and physical properties (tensile strength, elongation, powder residue, irritation, sensitization, cytotoxicity, toxicity) are provided.

Predicate Device(s)

K213408

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

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 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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/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

2

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.

3

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."

4

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."

6

510(K) SUMMARY

K230121

Applicant Name	CAREGLOVE GLOBAL SDN BHD
Location	Lot 17479, Lorong Senawang 2/3
Off Jalan Senawang 3,
Senawang Industrial Estate,
70450 Seremban,
Negeri Sembilan Darul Khusus,
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
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

8

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

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10

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
Holes	ASTM
D6319-19
ASTM
D5151-19	Meet requirement inspection level G-1, AQL 2.5	Pass
Dimension	ASTM
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
properties	ASTM
D6319-19		Pass
		Before Aging
		After Accelerated Aging
		Tensile
Strength
		Ultimate
Elongation
		Tensile
Strength
		Ultimate
Elongation
		14 MPa min.	500% min.
		14 MPa min.	400 % min.
Residual
Powder Content	ASTM
D6319-19
ASTM
D6124-06	Not more than 2 mg per glove	Pass
Biocompatibility
i) Primary Skin
Irritation	ISO 10993-
10	Not a primary skin irritant	Pass
ii) Skin
Sensitization	ISO 10993-
10	Not a contact sensitizer	Pass
iii) In Vitro
Cytotoxicity	ISO 10993-
5:2009	No adverse biological reaction	Moderate cytotoxicity
reactivity at 6.0 cm²/mL
and no reactivity at 3.0
cm²/mL extract
concentrations
iv) Acute
Systemic
Toxicity	ISO 10993-
11	No adverse biological reaction	Pass
Chemotherapy
Drug	Concentration	Minimum Breakthrough Detection Time
(minutes)	Remark

11

		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
(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:

1. Carmustine (BCNU) (3.3 mg/ml) 2. Thio Tepa (10 mg/ml) | | *Please note that following drugs have extremely low permeation times:
2. Carmustine (BCNU) (3.3 mg/ml)
3. 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.