← Product Code [LZA](/productcode/LZA) · K211808
# Medcare Powder-Free Blue Nitrile Patient Examination Gloves (K211808)
_Dongguan Grinvald Technology Co., Ltd. · LZA · Mar 4, 2022 · General Hospital · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K211808
## Device Facts
- **Applicant:** Dongguan Grinvald Technology Co., Ltd.
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Mar 4, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital
## Indications for Use
The powder free patient examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over the counter use.
## Device Story
Medcare Powder-Free Blue Nitrile Patient Examination Gloves are non-sterile, single-use, disposable nitrile gloves; ambidextrous; blue-colored; beaded cuff. Worn on examiner's hands to prevent cross-contamination between patient and examiner. Used in clinical or home settings by healthcare providers or patients. Device provides a physical barrier; no electronic or mechanical components. Benefits include protection against contamination during medical examinations.
## Clinical Evidence
Bench testing only. No clinical data provided. Testing included ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder), ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation and sensitization). All tests passed.
## Technological Characteristics
Material: Nitrile. Form factor: Ambidextrous, beaded cuff, blue-colored. Sizes: S, M, L, XL. Standards: ASTM D6319-10 (physical properties/dimensions), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization). Non-sterile, single-use. No software or electronic components.
## 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
- Powder Free Nitrile Examination Glove (Aqua green) ([K200326](/device/K200326.md))
## Submission Summary (Full Text)
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March 4, 2022 Dongguan Grinvald Technology Co., Ltd. % Aristotle Nafpliotis Regulatory Affairs Consultant/Engineer mdi Consultants, Inc. 55 Northern Blvd Great Neck, New York 11021
Re: K211808
Trade/Device Name: Medcare Powder-Free Blue Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 31, 2022 Received: February 1, 2022
Dear Aristotle Nafpliotis:
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.
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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray, III, 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) K211808
### Device Name
Medcare Powder-Free Blue Nitrile Patient Examination Gloves
Indications for Use (Describe)
The powder free patient examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over the counter use.
| 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)
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Image /page/3/Picture/0 description: The image shows a stylized, curved checkmark symbol. The checkmark is rendered in a gradient of blue, with darker shades suggesting depth and a three-dimensional effect. The design is simple and modern, with smooth lines that create a sense of fluidity and motion.
Dongguan Grinvald Technology CO., LTD. - China
## 510(k) SUMMARY
The assigned 5l0(k) number is: K211808.
#### 1. Submitter's Identification:
Date Summary Prepared: 4 March 2022
Dongguan Grinvald Technology Co.,Ltd. 401, Building3 No.4 of Guangming New Village 2 Road, Dongcheng , Dongguan City, Guangdong, China 523000
Contact: Dr. Anna Roxana Grinvald Email : anna@gts-hk.net Phone number 86 0769 23326470 Mobile phone no. 86 136 2261 7084
- 2. Name of the Device: Medcare Powder-Free Blue Nitrile Patient Examination Gloves
Model #: MD0120
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-powdered patient examination glove
Regulatory Class: Class 1
Product Code: LZA
#### 3. Information for the 510(k) Cleared Device (Predicate Device):
510(K) Number: K200326
Trade Name: Powder Free Nitrile Examination Glove (Aqua green)
Device Name: Nitrile Patient Examination Gloves
Device Classification Name: Patient Examination Gloves
Device Class: Class I
Product code LZA
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#### 4. Device Description:
Medcare Powder-Free Blue Nitrile Patient Examination Gloves are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder- free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in the following sizes:
| Module number | Size |
|---------------|------|
| MD0120S | S |
| MD0120M | M |
| MD0120L | L |
| MD0120XL | XL |
#### Indications for Use: 5.
The powder free patient examination gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over the counter use.
#### Comparison to the 510(k) Cleared Devices (Predicate Devices): 6.
# Comparison Chart
| Item | Acceptance Criteria | Subject Devices
Medcare Powder-Free
Blue Nitrile Patient
Examination Gloves
K211808 | Predicate Device
Powder Free Nitrile
Examination Glove
(Aqua green)
K200326 | Same,
Similar or
Different |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Product Code | LZA | LZA | LZA | Same |
| Intended
Use/Indications
for Use | --- | The powder free patient
examination gloves are
disposable devices
intended for medical
purposes that are worn | The Powder Free
Nitrile Examination
Glove (Aqua Green)
is a disposable device
intended for Medical | Similar* |
| | | on the examiner's hand
to prevent
contamination between
patient and examiner.
The device is for over
the counter use. | purpose that is worn
on the examiner's
hands or finger to
prevent
contamination patient
and examiner. | |
| Color | --- | Blue | Aqua Green | Different* |
| Materials | ASTMD6910-10
(Reapproved
2015) | Nitrile | Nitrile | Same |
| Sterility | --- | Non-sterile | Non-sterile | Same |
| Single Use | --- | Yes | Yes | Same |
| Dimensions (mm) | Overall Length
Min 230mm Width
(±5mm)
Size S = 85mm
Size M= 95mm
Size L = 105mm
Size XL = 115mm
Thickness at Palm
Min; 0.05 mm
Thickness at Finger
Tip
Min 0.05 mm | Meets ASTM D6319-
10 | Meets ASTM D6319-
10 | Same |
| Physical
properties | Before Ageing
Tensile
Strength (MPa)
Min 14min
Ultimate Elongation
(%)
= 500min After Aging
at 70oC for 168 hrs
@ 100oC for 22 hrs
Tensile Strength
(MPa) | Meets ASTM D6319-
10 | Meets ASTM D6319-
10 | Same |
| | = 14min
Ultimate Elongation
(%)
= 400min | | | |
| Freedom from
pinholes | AQL 2.5
Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-
06 | Same |
| Residual Powder | < 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-
06 | Same |
| Biocompatibility | | | | |
| Cytotoxicity
ISO 10993-5
Tests for in vitro
cytotoxicity of
medical devices | Non-cytotoxic | Pass | Pass | Same |
| Irritation
ISO 10993-10
Tests for irritation
and skin
sensitization | Non-Irritating | Pass | Pass | Same |
| Sensitization
ISO 10993-10
Tests for irritation
and skin
sensitization | Non-sensitizing | Pass | Pass | Same |
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*The items marked different and similar only differ in color and grammatical structure. These differences do not affect the overall substantial equivalence comparison as the former can be shown in the biocompatibility reports.
#### 7. Summary of Non-Clinical Tests Performed:
The following National and International Standards were utilized for testing the subject device:
• ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
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• ASTM D6124-06 (Reaffirmation 2011) Standard Test Method for Residual Powder on Medical Gloves
• ASTM D5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves
· ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
• ISO 10993-05:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
| Test Method | Purpose | Acceptance Criteria | Result |
|---------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------|
| ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application | To determine the
length of the gloves | Min 230 mm for all
sizes (±5mm) | Small: Pass
Medium: Pass
Large: Pass
X-Large: Pass |
| ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application | To determine the
width of the gloves | Small: 85mm
Medium: 95mm
Large: 105mm
X-Large: 115mm | Small: Pass
Medium: Pass
Large: Pass
X-Large: Pass |
| Test Method | Purpose | Acceptance Criteria | Result | | |
|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------|--------------|----------------|
| ASTM D6319-19
Standard Specification
for Nitrile
Examination Gloves
for Medical
Application | To determine
the length of
the gloves | Palm 0.05 mm min
Finger 0.05 mm min
for all sizes | Size
Small
Medium
Large
X-large | Palm
Pass | Finger
Pass |
| ASTM D6319-19
Standard Specification
physical properties-
for Nitrile
Examination Gloves
Ultimate Elongation
for Medical | To Determine
the physical
properties
Tensile
strength | Before Ageing
Tensile Strength
14Mpa Min for all
sizes | Size
Small
Medium | Pass | Pass |
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| Application | | | After Ageing | Large | | |
|-------------|----------------------------------------------------------------------|---------------|--------------------------------------|------------------|-----------------|------|
| | | | Tensile Strength | X-large | | |
| | | | 14Mpa Min for all
size | | | |
| | To Determine
the physical
properties
Ultimate
Elongation | Before Ageing | Size | Before
ageing | After
ageing | |
| | | | Ultimate
Elongation | | | |
| | | | Small | | | |
| | | | 500% Min for all
Size | Medium | Pass | Pass |
| | | After Ageing | Large | | | |
| | | | Ultimate | X-large | | |
| | | | Elongation 400%
Min for all sizes | | | |
| Test Method | Purpose | Acceptance
Criteria | Result |
|--------------------------------------------------------------------------------------|------------------------------------------------------|------------------------|---------------------------------------------|
| ASTM D5151-19
Standard Test Method
for detection of holes
in medical gloves | To determine the
holes in the gloves | AQL 2.5 | Pass |
| ASTM D6124-06
Standard Test Method
for Residual
Powder on Medical
Gloves | To determine the
residual powder in
the gloves | 2 Mg/Glove
Max | Size
Small
Medium
Large
X-Large |
| | | | Residual
Powder
Content
Pass |
| Test Method | Purpose | Acceptance
Criteria | Result |
|-----------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| ISO 10993-10:2010
Biological Evaluation of | To determine the
potential of the material
under test to produce | Under the
condition of study
not an irritant | Under the
condition of study
not an irritant |
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| Medical Devices Test for
Irritation and Skin
Sensitization. Test done
for irritation. | dermal irritation in
Rabbits | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| ISO10993-10:2010
Biological Evaluation of
Medical Devices Test for
Irritation and Skin
Sensitization. Test done
Skin sensitization. | To determine the skin
sensitization potential of
the material both in terms
of induction and
elicitation in Guinea Pig. | Under the
conditions of the
study not a
sensitizer | Under the
conditions of the
study not a
sensitizer |
| ISO 10993-5:2009
biological evaluation of
medical devices - part 5,
tests for in vitro
cytotoxicity. | To evaluate the in vitro
cytotoxic potential of the
test item (both inner and
outer surface) Extracts
in L-929 mouse
fibroblasts cells using
elution method. | Under the
conditions of study
non cytotoxic | Under the
conditions of the
study non
cytotoxic. |
#### 8. Discussion of Clinical Tests Performed:
Not applicable – Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
#### 9. Conclusions:
The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Medcare Powder-Free Blue Nitrile Patient Examination Gloves are as safe, effective, and perform as well as or better than the legally marketed predicate device cleared under K200326.
---
**Source:** [https://fda-staging.innolitics.com/device/K211808](https://fda-staging.innolitics.com/device/K211808)
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