← Product Code [LZA](/productcode/LZA) · K222892
# Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs (K222892)
_Grand Work Plastic Products Co., Ltd. · LZA · Dec 15, 2022 · General Hospital · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K222892
## Device Facts
- **Applicant:** Grand Work Plastic Products Co., Ltd.
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Dec 15, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital
## 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. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019)
## Device Story
Disposable, non-sterile, powder-free polyurethane examination gloves; ambidextrous; available in sizes XS-XXL. Designed to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05(2019). Used in clinical settings by healthcare professionals. Provides a physical barrier; protects the wearer from exposure to chemotherapy agents during handling. Warning provided for specific drugs with low breakthrough times (Carmustine, Thiotepa).
## Clinical Evidence
No clinical data. Bench testing only. Performance verified via ASTM D6319-19 (physical dimensions, tensile strength, elongation, water leak, powder residue) and ASTM D6978-05(2019) (chemotherapy permeation). Biocompatibility testing per ISO 10993-5, 10, 11, and 23 confirmed the device is non-irritating, non-sensitizing, and non-toxic.
## Technological Characteristics
Material: Polyurethane synthetic latex. Form: Powder-free, ambidextrous, blue color. Dimensions: 230mm minimum length, 0.05mm minimum thickness. Standards: ASTM D6319-19, ASTM D6978-05(2019), ASTM D5151-19, ASTM D6124-06, ASTM D412-16. Biocompatibility: ISO 10993-5, 10, 11, 23. Non-sterile.
## Regulatory 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
- Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) ([K203036](/device/K203036.md))
## Reference Devices
- Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) ([K222642](/device/K222642.md))
## Submission Summary (Full Text)
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December 15, 2022
Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K222892
Trade/Device Name: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: August 30, 2022 Received: September 23, 2022
Dear Kathy Liu:
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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Bifeng Qian -S
Bifeng Oian, 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 Ouality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K22892
#### Device Name
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
#### Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---------------------------------------|------------------------------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 24.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 0.6 |
* Please note that the following drugs have extremely low permeation times: Carmustine: 24.0 minutes, Thiotepa: 0.6 minutes
Warning: Do not use with Carmustine or Thiotepa.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Prescription Use (Part 21 CER 801 Subpart D) | X Over-The-Counter Use (21 CER 801 Subpart C) |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
#### 510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K222892 Date Prepared: November 20, 2022
### 1. Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Email: kathyliu@hongrayusa.com or fdareg(@)hongray.com.cn
#### 2. Name of the Device:
Trade Name: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialtv Classification Regulation: 21 CFR 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA, LZC, OPJ Device Class: Class I
#### 3. Predicate Device Information:
Central Medicare Sdn Bhd. Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)- (K203036)
#### Reference device:
Inner Mongolia Cureguard Medical Technology Co.,Ltd. Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) (K222642)
#### 4. Device Description:
Powder Free Polyurethane Examination Gloves, Blue color, tested for use with Chemotherapy Drugs are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. They are ambidextrous and come in different sizes-XS, S, M, L, XL and XXL. Gloves meet the specification of ASTM D6319-19
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
#### 5. Intended Use/Indication 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. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time
(BDT) in Minutes |
|---------------------------------------|---------------------------------------------------------|
| Carmustine 3.3 mg/ml (3,300 ppm) | 24.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 0.6 |
* Please note that the following drugs have extremely low permeation times:
Carmustine: 24.0 minutes, Thiotepa: 0.6 minutes
Warning: Do not use with Carmustine and Thiotepa.
#### 6.Comparison of Subject Device and Predicate Device:
The proposed and predicate device share the same technological characteristics and design by both meeting the standard specification ASTM D6319-19.
Biocompatibility study was performed on the proposed device. Under the conditions of the studies, the proposed devices are not sensitizers, irritants or systemic toxicity.
The proposed and predicate device are made from Polyurethane synthetic latex. The technological characteristics and design for the proposed device have been confirmed and the standard requirements that are appropriate for powder free polyurethane examinations gloves (ASTMD6319-19) have been met.
The following table of the device properties is a summary to show the technological characteristics of the proposed devices in relation to the predicate device:
| | Proposed Device
K222892 | Predicate Device
K203036 | Reference Device
K222642 | Comparison |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Trade Name | Powder Free
Polyurethane
Examination Gloves,
Blue color, Tested for | Non Sterile Powder
Free Polyurethane
Examination Gloves
(Blue and Black colors) | Disposable Nitrile
Examination Glove
(Tested for use with
Chemotherapy Drug) | Similar |
| | use with Chemotherapy
Drugs | | | |
| Product
Code | LZA, LZC, OPJ | LZA | LZA, LZC | Same as
K222642 |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | I | Same |
| Indications
for Use | Powder Free
Polyurethane
Examination Gloves,
Blue color, Tested for
use with Chemotherapy
Drugs is a disposable
device intended for
medical purposes that
is worn on the
examiner's hand to
prevent contamination
between patient and
examiner. Gloves have
been tested for use with
chemotherapy drugs
using ASTM D6978 | Non Sterile Powder
Free Polyurethane
Examination Gloves
(Blue and Black colors)
is a patient medical
exam glove which is a
disposable device
intended for medical
purpose that is worn on
the examiner's hand or
finger to prevent
contamination between
examiner and patient. | 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 | Same |
| Material | Polyurethane | Polyurethane | Nitrile | Same as
K203036 |
| Powder or
Powder Free | Powder Free | Powder Free | Powder Free | Same |
| Color | Blue | Blue and Black | Blue | Similar |
| Single use | Single use | Single use | Single use | Same |
| Design Feature | Ambidextrous | Ambidextrous | Ambidextrous | Same |
| Labeling
Information | Single-use indication,
powder free, device
name, glove size,
quantity, Polyurethane
Examination Gloves,
Non Sterile, tested for
use with Chemo-drugs | Single-use indication,
powder free, device
name, glove size,
quantity, Polyurethane
Examination Gloves,
Non Sterile | Single-use indication,
powder free, device
color, device name,
glove size and quantity,
Non-Sterile, a
statement of standard
ASTM D6978-05
compliance and a
summary of the testing
results | Similar |
| Technological
Characteristics | Proposed
Device
K222892 | Predicate
Device
K203036 | Reference
Device
K222642 | Comparison |
| Length | Minimum
230mm | Minimum
230mm | Minimum 230mm | Same |
| Palm Width (size) (mm) | | | | |
| XS | 70±10 | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | 120±10 | Same |
| XXL | 130±10 | N/A | N/A | Different |
| Thickness(mm) | | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength,
Before Aging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate
Elongation,
Before Aging | 500%, min | 500%, min | 500%, min | Same |
| Tensile Strength,
After Accelerated
Aging | 14MPa, min | 14MPa, min | 14MPa, min | Same |
| Ultimate
Elongation, After
Accelerated Aging | 400%, min | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20 ASTM
D5151 AQL 2.5 | 21 CFR 800.20
ASTM D5151 | 21 CFR 800.20
ASTM D5151 | Same |
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| ISO 10993-10&23
Skin Irritation and
Sensitization Study | Under the conditions
of the study, not an
irritant, not a
sensitizer | Under the conditions
of the study, the
subject device is non-
irritating and non-
sensitization | Under the conditions
of the study, not an
irritant, not a
sensitizer | Same |
| ISO 10993-5
Cytotoxicity Test | showed potential
toxicity to L929 cells | N/A | Under conditions of
the study, device
extract is cytotoxic. | Similar |
| ISO 10993-11Acute
systemic toxicity | no evidence of acute
systemic toxicity | N/A | Under conditions of
the study, device
extract is non-toxic. | Same |
| Tested Chemotherapy Drug and
Concentration | Minimum BDT (Minutes) | | Comparison | |
| | Proposed Device
K222892 | Reference Device
K222642 | | |
| Carmustine 3.3 mg/ml (3,300 ppm) | 24.0 | 22.0 | Similar | |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same | |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same | |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same | |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same | |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same | |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same | |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | N/A | Different | |
| Mitomycin C (0.5 mg/ml) | N/A | >240 | Different | |
| Vincristine sulfate (1.0 mg/ml) | N/A | >240 | Different | |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same | |
| Thiotepa, 10mg/ml (10,000ppm) | 0.6 | 59.2 | Similar | |
General Comparison Table:
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##
Donggao Industrial Zone, Zhanhuang, Hebei, 050000, China
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Technological Characteristic Comparison Table:
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
### Chemotherapy Permeation Comparison Claim:
#### 7. Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------|---------|
| ASTM D6319- 19 | Physical Dimensions
Length | Minimum 230mm for all sizes | Pass |
| ASTM D6319- 19 | Physical Dimensions
Palm Width | XS: 70±10mm
S: 80±10mm
M: 95±10mm
L:110±10mm
XL: 120±10mm
XXL: 130±10mm | Pass |
| ASTM D6319- 19 | Physical Dimensions
Thickness | Finger: 0.05mm (min)
Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19
ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 Mpa) and Elongation
(Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319- 19
ASTM D5151-19 | Water leak test | AQL 2.5 | Pass |
| ASTM D6319- 19
ASTM D6124-06 (2017 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by
Chemotherapy Drugs | Refer the above table | Pass |
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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
| ISO 10993-10
&23:2021 | Irritation And Skin
Sensitization | No Skin sensitization and
No Skin irritation | Is non-sensitization
and Non-irritation |
|--------------------------|--------------------------------------|--------------------------------------------------|------------------------------------------------|
| ISO 10993-5:2009 | Cytotoxicity | Not Cytotoxic | showed potential
toxicity to L929
cells. |
| ISO 10993-11:2017 | Acute systemic toxicity
study | Subject showed no adverse
biological reaction | no evidence of acute
systemic toxicity. |
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical ● Application.
- . ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on ● Medical Gloves
- . ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For . Skin Sensitization.
- ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 10: Tests For ● Skin Irritation.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In . Vitro Cytotoxicity
- . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
#### 8. Clinical Performance Data
N/A
#### 9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
---
**Source:** [https://fda-staging.innolitics.com/device/K222892](https://fda-staging.innolitics.com/device/K222892)
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