Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)

• K Number: K232252
• Device Name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
• Manufacturer: Dehai (Shandong) Medical Gloves, Co., Ltd.
• Date Cleared: 2023-11-28 ( 123 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 as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Description

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large.

Predicate Devices

K230121

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the physical and chemical properties of examination gloves, with no mention of AI or ML.

Therapeutic

No.

The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat a medical condition.

Diagnostic

No

Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It is a barrier device, not a diagnostic device that detects or identifies a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical glove made from synthetic rubber latex, which is a hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand or finger to prevent contamination between patient and examiner. This is a barrier device used in vivo (on a living person), not a device used in vitro (outside the body) to examine specimens.
• Device Description: The description reinforces that it's a glove made from synthetic rubber latex, worn on the hand.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological specimens (blood, urine, tissue, etc.)
  • Providing diagnostic information about a patient's condition
  • Using reagents or assays
  • Measuring analytes

The testing for chemotherapy drug and fentanyl permeation is related to the glove's barrier properties and safety for the user, not its use in diagnosing a condition.

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 as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Product codes

LZA, LZC, ODO, OPJ

Device Description

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large.

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)

Non-Clinical Testing:
The gloves were tested for:

• Freedom From Holes (ASTM D6319-19, ASTM D5151-19, Acceptance Criteria: Meet requirement inspection level G-1, AQL 2.5,Sampling size125pcs(Ac: 7,Re: 8)). Black Pass (≤3pcs), Orange Pass (≤4pcs).
• Dimension (ASTM D6319-19, Acceptance Criteria: Length 220 mm min (small) / 230 mm min (other sizes); Width(mm) S: 80±10, M: 95±10, L: 110±10, XL: 120±10, XXL: 130±10; Thickness(mm) Palm: Minimum 0.05, Finger: Minimum 0.05). Black Pass (241 mm min; S: average 85.5mm, M: average 96.3mm, L: average 106.4mm, XL: average 115.5mm, XXL: average 125.1mm; Palm - 0.178mm min., Finger-0.199mm min). Orange Pass (240 mm min; S: average 85.8mm, M: average 96.1mm, L: average 106.8mm, XL: average 115.9mm, XXL: average 125.6mm; Palm - 0.181mm min., Finger-0.212mm min).
• Physical properties (ASTM D6319-19, Acceptance Criteria: Before Aging: Tensile Strength: 14 MPa, min., Elongation: 500%, min.; After Aging: Tensile Strength: 14 MPa, min., Elongation: 400%, min.). Black Pass (Before Aging: Tensile Strength: 15.1 MPa, min., Elongation: 518%, min.; After Aging: Tensile Strength: 15.0MPa, min., Elongation: 460%, min.). Orange Pass (Before Aging: Tensile Strength: 15.3 MPa, min., Elongation: 502%, min.; After Aging: Tensile Strength: 14.1MPa, min., Elongation: 462%, min.).
• Residual Powder Content (ASTM D6319-19, ASTM D6124-06, Acceptance Criteria: Not more than 2 mg per glove). Black Pass (average 0.32mg), Orange Pass (average 0.30mg).
• Biocompatibility:
  • Primary Skin Irritation Test (ISO 10993-23 new version (ISO 10993-10), Acceptance Criteria: Not a primary skin irritant). Both Black and Orange tested Pass.
  • Skin Sensitization Test (ISO 10993-10, Acceptance Criteria: Not a contact sensitizer). Both Black and Orange tested Pass.
  • Acute Systemic Toxicity (ISO 10993-11, Acceptance Criteria: No systemic toxicity). Both Black and Orange tested Pass.
• Chemotherapy Drug Permeation (ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs).
  • Carmustine (3.3mg/ml (3,300 ppm)): Black 21.6 min, Orange 22.7 min.
  • Cyclophosphamide (20 mg/ml (20.000 ppm)): Black >240 min, Orange >240 min.
  • Doxorubicin HCl (2 mg/ml (2,000 ppm)): Black >240 min, Orange >240 min.
  • Etoposide (20mg/ml (20,000 ppm)): Black >240 min, Orange >240 min.
  • Fluorouracil (50 mg/ml(50,000 ppm)): Black >240 min, Orange >240 min.
  • Mitomycin C (50 mg/ml(500 ppm)): Black >240 min, Orange >240 min.
  • Oxaliplatin (5 mg/ml (5,000 ppm)): Black >240 min, Orange >240 min.
  • Paclitaxel (6 mg/ml (6,000 ppm)): Black >240 min, Orange >240 min.
  • Thiotepa (10 mg/ml (10,000 ppm)): Black 28 min, Orange 37.1 min.
  • Fentanyl Citrate Injection (100mcg/2mL): Black >240 min, Orange >240 min.

Clinical Testing:
Not applicable.

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

Not Found

Predicate Device(s)

K230121

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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

November 28, 2023

Dehai (Shandong) Medical Gloves, Co., Ltd. % Deze Wang Official Correspondent Intco Medical Industries, Inc 805 Barrington Ave. Ontario, California 91764

Re: K232252

Trade/Device Name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) 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: October 26, 2023 Received: October 30, 2023

Dear Deze Wang:

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

1

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 Ouality System (OS) 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 QS 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).

2

Sincerely,

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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

510(k) Number (if known) K232252

Device Name

Nittile Powder Free Examination Gloves Tested for Use with Chemotherapy Drues and Fentaxy, Citrate (Black), Nittle Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange).

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 as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drugs and Fentanyl

Concentration		Minimum Breakthrough Detection Time (minutes)
		Black	Orange
*Carmustine	3.3mg/ml (3,300 ppm)	21.6	22.7
Cyclophosphamide	20 mg/ml (20.000 ppm)	>240 min.	>240 min.
Doxorubicin HCl	2 mg/ml (2,000 ppm)	>240 min.	>240 min.
Etoposide	20mg/ml (20,000 ppm)	>240 min.	>240 min.
Fluorouracil	50 mg/ml(50,000 ppm)	>240 min.	>240 min.
Mitomycin C	50 mg/ml(500 ppm)	>240 min.	>240 min.
Oxaliplatin	5 mg/ml (5,000 ppm)	>240 min.	>240 min.
Paclitaxel	6 mg/ml (6,000 ppm)	>240 min.	>240 min.
*Thiotepa	10 mg/ml (10,000 ppm)	28	37.1
Fentanyl Citrate Injection	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

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

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

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4

510(K) SUMMARY K232252

(As requirement by 21 CFR 807.92)

Applicant Name	Dehai (Shandong) Medical Gloves, Co., Ltd.
Location	No. 216 Huagong Road Linzi District, Zibo City,
Shandong Province, China
Contact Person:	Li xiaomeng
Tel:	[phone]
Date summary prepared:	16th Nov. 2023
Device Information
Trade Name:	Nitrile Powder Free Examination Gloves Tested for Use with Ch
Trade Name:	Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy
Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves
Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
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

NITRILE EXAMINATIONGLOVES POWDERFREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE(BLUE & BLACK), 510(K) number K230121 product code LZA, LZC, QDO, OPJ.

Device Description

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large. The Nitrile Examination Gloves Powder Free (Black & Orange) have been tested for Chemotherapy Drugs and Fentanyl Citrate as below:

5

DH Medical

| Chemotherapy Drugs and

Fentanyl	Concentration	Minimum Breakthrough Detection Time (minutes)
		Black	Orange
* Carmustine	3.3mg/ml (3,300 ppm)	21.6	22.7
Cyclophosphamide	20 mg/ml (20.000 ppm)	>240 min.	>240 min.
Doxorubicin HCI	2 mg/ml (2,000 ppm)	>240 min.	>240 min.
Etoposide	20mg/ml (20,000 ppm)	>240 min.	>240 min.
Fluorouracil	50 mg/ml(50,000 ppm)	>240 min.	>240 min.
Mitomycin C	50 mg/ml(500 ppm)	>240 min.	>240 min.
Oxaliplatin	5 mg/ml (5,000 ppm)	>240 min.	>240 min.
Paclitaxel	6 mg/ml (6,000 ppm)	>240 min.	>240 min.
* Thiotepa	10 mg/ml (10,000 ppm)	28	37.1
Fentanyl Citrate Injection	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

and Fentanyl	Concentration	Minimum Breakthrough Detection Time (minutes)
		Black	Orange
* Carmustine	3.3mg/ml (3,300 ppm)	21.6	22.7
Cyclophosphamide	20 mg/ml (20.000 ppm)	>240 min.	>240 min.
Doxorubicin HCI	2 mg/ml (2,000 ppm)	>240 min.	>240 min.
Etoposide	20mg/ml (20,000 ppm)	>240 min.	>240 min.
Fluorouracil	50 mg/ml(50,000 ppm)	>240 min.	>240 min.
Mitomycin C	50 mg/ml(500 ppm)	>240 min.	>240 min.
Oxaliplatin	5 mg/ml (5,000 ppm)	>240 min.	>240 min.
Paclitaxel	6 mg/ml (6,000 ppm)	>240 min.	>240 min.
* Thiotepa	10 mg/ml (10,000 ppm)	28	37.1
Fentanyl Citrate Injection	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

6

Summary of The Technological Characteristic

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange), are summarized with the following technological characteristic compared to ASTM D6319 or equivalent standards.

| Characteristic | Standard | Subject Device
K232252 | Predicate Device
K230121 | Remarks | |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--|
| Product Code | - | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | 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 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. | 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 Chlorinated,
Powder Free Nitrile | Ambidextrous, Polymer
Coated or Chlorinated,
Powder Free Nitrile | Similar | |
| Color Description | - | Black & Orange | Blue & Black | 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 | Similar | |
| Sterility | - | Non-Sterile | Non-Sterile | Same | |
| Dimension | - | | | | |
| Length
S, M, L, XL, XXL | ASTM D6319- 19 | Meet 220mm min for S
Meet 230mm min for other sizes | Meet 220mm min for small
Meet 230mm min for other sizes | Similar | |
| Thickness (palm),
Thickness (finger), | - | Meet 0.05mm min
Meet 0.05mm min | Meet 0.05mm min
Meet 0.05mm min | Similar | |
| Width | - | S: Meet $80 \pm 10$ mm
M: Meet $95 \pm 10$ mm
L: Meet $110 \pm 10$ mm
XL: Meet $120 \pm 10$ mm
XXL: Meet $130 \pm 10$ 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 | Similar | |
| Characteristic | Standard | Subject Device
K232252 | Predicate Device
K230121 | 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 | Same | |
| (After Aging)
i) Tensile Strength
(MPa)
ii) Ultimate
Elongation (%)
Water Leak Test, | | Meets 14MPa min
Meet 400% min. | Meets 14MPa min
Meet 400% min. | Same | |
| 1000 ml
Before Aging, AQL | ASTM D6319- 19
ASTM D5151-19 | Passes at AQL 2.5
Meet the ASTM D
6319-19 requirement | Passes at AQL 1.5 | Different | |
| Powder Free
Residue
Powder Free | ASTM D6319- 19
ASTM D6124-06 | Meet 2mg/glove max. | Meet 2mg/glove max. | Same | |
| Residue, mg/ glove | | | | | |
| Biocompatibility
Test | | | | | |
| i) Primary Skin
Irritation Test | ISO 10993-23 new
version
(ISO 10993- 10) | Passes
Conclusion: The test result
showed that the response of
the test article was
categorized as negligible
under the test condition | Passes
Conclusion: Under the
conditions of this study the
test material did not cause an
irritant response | Similar | |
| ii) Skin Sensitization
Test | ISO 10993- 10 | Passes
Conclusion: Under the
conditions of this study, the test
article showed no significant
evidence of causing skin
sensitization in the guinea pig | Passes
Conclusion: Under the
conditions of this study, the
test material did not produce a
skin sensitization effect | Similar | |
| iii) Acute
Systemic Toxicity | ISO 10993- 11 | Conclusion: Under the
conditions of this study, there
was no evidence of acute
systemic toxicity from the
extract. The test article extract
met the requirements of the
study. | Conclusion: Under the
conditions of this study, the
test material showed no
adverse biological reaction
after administration of the
sample's extract on the rats
during the period of the
study. | Similar | |
| Black color | | | | | |
| Test | Method | Acceptance Criteria | Result | | |
| Freedom From
Holes | ASTM
D6319-19
ASTM
D5151-19 | Meet requirement inspection level
G- 1, AQL 2.5
Sampling size125pcs(Ac: 7,Re: 8) | Pass
≤3pcs | | |
| Dimension | ASTM
D6319-19 | Length
220 mm min (small)
230 mm min (other sizes)
Width(mm)
S: 80±10
M: 95±10
L : 110±10
XL : 120±10
XXL : 130±10
Thickness(mm):
Palm: Minimum 0.05
Finger: Minimum 0.05 | Pass
241 mm min
Pass
S: average 85.5mm
M: average 96.3mm
L: average 106.4mm
XL: average 115.5mm
XXL: average 125.1mm
Pass
Palm - 0.178mm min.
Finger-0.199mm min | | |
| Physical
properties | ASTM
D6319-19 | Before Aging:
Tensile Strength: 14 MPa, min.
Elongation: 500%, min.
After Aging:
Tensile Strength: 14 MPa, min.
Elongation: 400%, min. | Pass
Before Aging:
Tensile Strength: 15.1 MPa, min.
Elongation: 518%, min.
After Aging:
Tensile Strength: 15.0MPa, min.
Elongation: 460%, min. | | |
| Residual
Powder Content | ASTM
D6319-19
ASTM
D6124-06 | Not more than 2 mg per glove | Pass
average 0.32mg | | |
| Biocompatibility
i) Primary Skin
Irritation
ii) Skin
Sensitization
iii) Acute
Systemic
Toxicity | ISO 10993-23
ISO 10993-10
ISO 10993-11 | Not a primary skin irritant
Not a contact sensitizer
No systemic toxicity | Pass
Pass
Pass | | |
| Chemotherapy
Drug | Concentration | Minimum Breakthrough Detection
Time (minutes) | Remark | | |

7

8

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.

9

DH Medical

Orange color
Test	Method	Acceptance Criteria	Result
Freedom From
Holes	ASTM
D6319-19
ASTM
D5151-19	Meet requirement inspection level
G- 1, AQL 2.5
Sampling size125pcs(Ac: 7,Re: 8)	Pass
≤4pcs
Dimension	ASTM
D6319-19	Length
220 mm min (small)
230 mm min (other sizes)
Width(mm)
S: 80±10
M: 95±10
L : 110±10
XL : 120±10
XXL : 130±10
Thickness(mm):
Palm:Minimum 0.05
Finger:Minimum 0.05	Pass
240 mm min
Pass
S: average 85.8mm
M: average 96.1mm
L: average 106.8mm
XL: average 115.9mm
XXL: average 125.6mm
Pass
Palm - 0.181mm min.
Finger-0.212mm min
Physical
properties	ASTM
D6319-19	Before Aging:
Tensile Strength: 14 MPa, min.
Elongation: 500%, min.
After Aging:
Tensile Strength: 14 MPa, min.
Elongation: 400%, min.	Pass
Before Aging:
Tensile Strength: 15.3 MPa, min.
Elongation: 502%, min.
After Aging:
Tensile Strength: 14.1MPa, min.
Elongation: 462%, min.
Residual
Powder Content	ASTM
D6319-19
ASTM
D6124-06	Not more than 2 mg per glove	Pass
average 0.30mg
Biocompatibility	i) Primary Skin
Irritation	ISO 10993-23
Not a primary skin irritant	Pass
	ii) Skin
Sensitization	ISO 10993-10
Not a contact sensitizer	Pass
	iii) Acute
Systemic
Toxicity	ISO 10993-11
No acute systemic toxicity	Pass
Chemotherap
y Drug and
Fentanyl	Concentration	Minimum Breakthrough Detection
Time (minutes)	Remark

10

		Proposed Device		Predicate Device
		Black	Orange	Blue	Black
* Carmustine ( BCNU)	3.3 mg/ml	21.6	22.7	22.6	21.8	Different
Cyclophosphamide	20.0 mg/ml	>240 min	>240 min	>240 min	>240 min	Same
Doxorubicin HCL	2.0 mg/ml	>240 min	>240 min	>240 min	>240 min	Same
Etoposide	20.0 mg/ml	>240 min	>240 min	>240 min	>240 min	Same
Fluorouracil	50.0 mg/ml	>240 min	>240 min	>240 min	>240 min	Same
Paclitaxel	6.0 mg/ml	>240 min	>240 min	>240 min	>240 min	Same
* Thio Tepa	10.0 mg/ml	28	37.1	43.9	17.7	Different
Mitomycin C	0.5mg/ml	>240 min	>240 min	Not test	Not test	Different
Oxaliplatin	5mg/ml	>240 min	>240 min	Not test	Not test	Different
Dacarbazine	10.0 mg/ml	Not test	Not test	>240 min	>240 min	Different
Ifosfamide	50.0 mg/ml	Not test	Not test	>240 min	>240 min	Different
Cisplatin	1.0 mg/ml	Not test	Not test	>240 min	>240 min	Different
Mitoxantrone	2 mg/ml	Not test	Not test	>240 min	>240 min	Different
Vincristine Sulfate	1.0 mg/ml	Not test	Not test	>240 min	>240 min	Different
Fentanyl Citrate	100mcg/2ml	>240 min	>240 min	>240 min	>240 min	Same
Warning		Please note that following
drugs have extremely low
permeation times:		*Please note that following
drugs have extremely low
permeation times:		Similar
		1. Carmustine (BCNU) (3.3 mg/ml)		1. Carmustine (BCNU) (3.3 mg/ml)
		2. Thio Tepa (10 mg/ml)		2. Thio Tepa (10 mg/ml)

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, K230121,Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)