(86 days)
Not Found
No
The device is a physical examination glove and the summary focuses on material properties and physical dimensions, with no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
This device, a nitrile patient examination glove, is intended to prevent contamination between patient and examiner. It is a barrier device, not one that gathers or analyzes data for diagnosis.
No
The device is a physical nitrile glove, not a software application. The description focuses on material properties and physical dimensions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and manufacturing of a glove.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on the physical integrity, dimensions, watertightness, and biocompatibility of the glove, which are relevant to its barrier function, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
White Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
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's hand or finger
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 tests were performed.
Physical Properties test according to ASTM D412:
- Tensile strength (Before aging): XS – 28.8, S – 28.6, M – 28.9, L – 28.1, XL – 28.7 (all Pass, Min 14.0 MPa)
- Tensile strength (After aging): XS – 30.8, S – 31.1, M – 31.8, L – 31.9, XL – 30.8 (all Pass, Min 14.0 MPa)
- Ultimate elongation (Before aging): XS – 540, S – 540, M – 530, L – 540, XL – 540 (all Pass, Min 500%)
- Ultimate elongation (After aging): XS – 460, S – 480, M – 480, L – 480, XL – 480 (all Pass, Min 400%)
Dimension test according to ASTM D3767: - X-Small: Length 248 mm (Pass, Min 240 mm), Width 75 mm (Pass, 70 +/- 10 mm), Thickness Finger 0.09 mm (Pass, min 0.05mm), Palm 0.06 mm (Pass, min 0.05mm)
- Small: Length 245 mm (Pass, Min 240 mm), Width 85 mm (Pass, 80 +/- 10 mm), Thickness Finger 0.09 mm (Pass, min 0.05mm), Palm 0.06 mm (Pass, min 0.05mm)
- Medium: Length 244 mm (Pass, Min 240 mm), Width 95 mm (Pass, 95 +/- 10 mm), Thickness Finger 0.09 mm (Pass, min 0.05mm), Palm 0.06 mm (Pass, min 0.05mm)
- Large: Length 248 mm (Pass, Min 240 mm), Width 106 mm (Pass, 110 +/- 10 mm), Thickness Finger 0.09 mm (Pass, min 0.05mm), Palm 0.06 mm (Pass, min 0.05mm)
- X-Large: Length 244 mm (Pass, Min 240 mm), Width 116 mm (Pass, 120 +/- 10 mm), Thickness Finger 0.09 mm (Pass, min 0.05mm), Palm 0.06 mm (Pass, min 0.05mm)
Watertight test according to ASTM D5151: - Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10.
- XS: 1 piece with leaks (Pass)
- S: 2 pieces with leaks (Pass)
- M: 2 pieces with leaks (Pass)
- L: 4 pieces with leaks (Pass)
- XL: 3 pieces with leaks (Pass)
Residual Powder test according to ASTM D6124: - Sample size: 5 pcs, Requirement:
§ 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.
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 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.
December 3, 2022
Safeskin Retailing (HK) Limited % Stephan Toupan President Dawa Medical LLC 7320 NW 12th Street Suite 103 Miami, Florida 33126
Re: K222713
Trade/Device Name: White Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 5, 2022 Received: September 8, 2022
Dear Stephan Toupan:
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); medical device reporting (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222713
Device Name WHITE NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE
Indications for Use (Describe)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
| 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) |
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3
Image /page/3/Picture/0 description: The image contains the logo for Safeskin Retailing. The logo consists of a blue geometric shape on the left and the words "safeskin retailing" on the right. The geometric shape is a stylized letter "K" formed by two triangles, one in a darker shade of blue and the other in a lighter shade. The text "safeskin retailing" is in a bold, sans-serif font, with "safeskin" on the top line and "retailing" on the bottom line.
K222713 510K Summary
Trade Name : White Nitrile Powder-free Patient
Examination Glove, Non-Sterile
4
1.0 Submitter:
| Name | : | Alvin Ho |
|---|---|---|
| Address | : | Safeskin Retailing (HK) Limited |
| 26th Floor, Beautiful Group Tower, 77 Connaught Road | ||
| Central, Hong Kong | ||
| Phone No. | : | +6012 826 5625 |
| Date of Summary Prepared | : | 8/1/2022 |
2.0 ldentification of the subject device:
| Trade Name: | White Nitrile Powder-Free Patient Examination Glove, Non-
Sterile |
|------------------------|----------------------------------------------------------------------|
| Common Name: | Patient Examination Gloves |
| Classification Name : | Patient Examination Gloves |
| Device Classification: | 1 |
| Regulation Number : | 21 CFR 880.6250 |
| Product Code: | LZA |
3.0 Predicate Device:
K171615
Xingyu Nitrile Powder Free Patient Examination Gloves, White Color Company: Shandong Xingyu Gloves Co., Ltd
4.0 Description of The Subject Device:
White Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
5.0 Indication for use:
A Nitrile 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.
6.0 Comparison of the Technological Characteristics of the Device:
The White Nitrile Powder-Free Patient Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1
5
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | ||
|---|---|---|---|---|---|
| PREDICATE | |||||
| WHITE | CURRENT | ||||
| WHITE | |||||
| 510(k) Number | - | K171615 | K222713 | ||
| Manufacturer(s) | - | Shandong Xingyu Gloves Co., Ltd | Safeskin Retailing (HK) Limited | Same | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same | |
| Color | - | White | White | Same | |
| Sterility | - | Non-Sterile | Non-Sterile | Same | |
| Handedness | - | Ambidextrous | Ambidextrous | Same | |
| Physical Properties | Before Aging | ||||
| Tensile Strength: | |||||
| Ultimate Elongation: | ASTM D6319 | 18-25Mpa | |||
| 560-600% | 28.1 – 32.9 Mpa | ||||
| 530 - 600% | Different but | ||||
| within the ASTM | |||||
| standard | |||||
| After Aging Tensile | |||||
| Strength: | |||||
| Ultimate Elongation: | 17-21Mpa | ||||
| 460-560% | 30.8 – 35.9 Mpa | ||||
| 460 - 560% | Different but | ||||
| within the ASTM | |||||
| standard | |||||
| Thickness: | - Finger |
- Palm | ASTM D6319 | 0.08mm
0.08mm | Min 0.09mm for (XS, S, M, L XL)
Min 0.06mm for (XS, S, M, L, XL) | Different but
within the ASTM
standard |
| | Powder Free | | | ASTM D6124 | Below 2mg of residual powder |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON
ANALYSIS | |
| | | PREDICATE | CURRENT | | |
| | | WHITE | WHITE | | |
| Biocompatibility | Primary Skin Irritation - ISO 10993-10:2010
(E) & Consumer
Product Safety
Commission Title 16,
Chapter II, Part 1500 | Under the conditions of this
study, the test article was a non-
irritant or non-sensitizer.
SKIN IRRITATION DERMAL and
SENSITIZATION STUDIES Meets
ISO 10993-10: Third Edition
2010-08-01 | Under conditions of this study, the
test material did not cause an
irritant response. The Primary
Irritant Response Category is
deemed 'Negligible' | Same | |
| | Dermal Sensitization-
ISO 10993-10: 2010
(E) & Consumer Product
Safety Commission,
Title 16,Chapter II, Part
1500.3 (c) (4) | Under the conditions of this
study, the test article was a non-
irritant or non-sensitizer.
SKIN IRRITATION DERMAL and
SENSITIZATION STUDIES
Meets ISO 10993-10: Third
Edition 2010-08-01 | Under conditions of this study,the
test material did not produce a skin
sensitization effect in the guinea
pigs. | Same | |
| | Acute Systemic
Toxicity, ISO 10993-
11:2017 (E) | Not Tested | Under conditions of this study,the
test item did not induce any
acute systemic toxicity in Swiss
albino mice. | Different. The
subject glove was
tested using
systemic toxicity test
and passed, but the
Predicate did not
have the test
performed | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON
ANALYSIS | |
| | | PREDICATE
WHITE | CURRENT
WHITE | | |
| Watertight (1000ml) | ASTM D5151:2019 | Meets 21 CFR 800.20 ASTM D6319-10
(Reapproved 2015) Tested in accordance with ASTM
D5151 (Reapproved 2015) with
acceptable results | Meets 21 CFR 800.20 ASTM D6319-10
(Reapproved 2015) Tested in accordance with ASTM
D5151 (Reapproved 2015) with
acceptable results
At an AQL 1.5 | Same | |
| Intended use | - | Powder Free Nitrile Patient
Examination Gloves, White Color is
a disposable device intended for
medical purposes that is worn on
the examiner'shand or finger to
prevent contamination between
patientand examiner. | A Nitrile patient examination glove
is a disposable device made of
nitrile rubber intended for medical
purposes that is worn on the
examiner's hand or finger to
prevent contamination between
patient and examiner. | Same | |
| Size | Medical Glove
Guidance Manual -
Labeling | Small
Medium
Large
X Large | Extra Small
Small
Medium
Large
Extra Large | Similar
The subject glove
has an additional
size Extra Small,
which the Predicate
does not offer | |
| Single use | Medical Glove
Guidance Manual –
Labeling | Single Patient Use | Single Use | Same | |
6
7
8
There are no significant differences between the two devices. They are the same or similar in terms of intended use, primary material (Nitrile), design, physical properties, thickness, powder-free compliance, color, and biocompatibility assessments.
Summary of Non-Clinical Testing 7.0
The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below.
9
| Test
| Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |||
|---|---|---|---|---|---|---|---|---|
| Physical | ||||||||
| Properties | ASTM D412 | |||||||
| (Standard Test Method | ||||||||
| for Vulcanized Rubber | ||||||||
| and Thermoplastic | ||||||||
| Elastomers-Tension) | To evaluate the | |||||||
| tensile (tension) | ||||||||
| properties of glove. | Tensile | |||||||
| strength | Before | |||||||
| aging | After | |||||||
| aging | Before | |||||||
| aging | After aging | |||||||
| Min 14.0 | ||||||||
| MPa | Min 14.0 | |||||||
| MPa | XS – 28.8 | XS – 30.8 | Pass | |||||
| S – 28.6 | S – 31.1 | |||||||
| M – 28.9 | M – 31.8 | |||||||
| L – 28.1 | L – 31.9 | |||||||
| XL – 28.7 | XL – 30.8 | |||||||
| Ultimate | ||||||||
| elongation | Min | |||||||
| 500% | Min | |||||||
| 400% | XS – 540 | XS – 460 | Pass | |||||
| S – 540 | S – 480 | |||||||
| M – 530 | M – 480 | |||||||
| L – 540 | L – 480 | |||||||
| XL – 540 | XL – 480 |
10
| Test
Method | Standard | Purpose of
Testing | Glove
Size | Acceptance Criteria | Results | Status | |
|----------------|----------------------------------------------------------------------------------|-----------------------------------------------------------|---------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------|------|
| Dimension | ASTM D3767
Standard
Practice for
Rubber—
Measurementof
Dimensions | To measure the
length, width and
thickness of glove | X-Small | Length
Min 240 mm
Width
$70 \pm 10$ mm
Thickness
Finger – min 0.05mm
Palm - min 0.05mm | Length
248 mm
Width
75 mm
Thickness
0.09 mm
0.06 mm | Pass
Pass
Pass | |
| | | | Small | Length
Min 240 mm
Width
$80 \pm 10$ mm
Thickness
Finger – min 0.05mm
Palm - min 0.05mm | Length
245 mm
Width
85 mm
Thickness
0.09 mm
0.06 mm | Pass
Pass
Pass | |
| | | | Medium | Length
Min 240 mm
Width
$95 \pm 10$ mm
Thickness
Finger – min 0.05mm
Palm - min 0.05mm | Length
244 mm
Width
95 mm
Thickness
0.09 mm
0.06 mm | Pass
Pass
Pass | |
| | | | Large | Length
Min 240 mm
Width
$110 \pm 10$ mm | Length
248 mm
Width
106 mm | Pass
Pass | |
| | | | Thickness | Finger – min 0.05mm | Thickness | 0.09 mm | Pass |
| | | | | Palm – min 0.05mm | | 0.06 mm | |
| | | | Length | Min 240 mm | Length | 244 mm | Pass |
| | | X-Large | Width | $120 \pm 10$ mm | Width | 116 mm | Pass |
| | | | Thickness | Finger – min 0.05mm | Thickness | 0.09 mm | Pass |
| | | | | Palm – min 0.05mm | | 0.06 mm | |
11
12
| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
|--------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Watertight | ASTM D5151
(Standard Test
Method for
Detection of Holesin
Medical Gloves) | To detect holes
that leak water and
thereby
compromise the
usefulness of the
glove. | Sample size: 315 pcs
Inspection level: G1
AQL: 1.5, Acceptance No. 10 | The batch size for this
sampling is 150,001 to
500,000. Hence,
according to the single
sampling plan GI, the
sample to be drawn is
under code M equivalent
to 315 pieces with accept
10 and reject 11 to be
accepted under AQL
1.5.
For Size XS During the
test, 1piece was found
with leaks. Hence it falls
within the acceptance
criteria.
For Size S During the
test, 2piece was found
with leaks. Hence it falls
within the acceptance
criteria.
For Size M During the
test, 2piece was found
with leaks. Hence it falls
within the acceptance
criteria.
For Size L During the
test, 4piece was found
with leaks. Hence it falls
within the acceptance
criteria.
For Size XL During the
test, 3piece was found
with leaks. Hence it falls
within the acceptance
criteria. | Pass |
| Test
Method | Standard | Purpose of
Testing | Acceptance Criteria | Results | Status |
| Residual
Powder | ASTM D6124
(Standard Test Method
for Residual Powder on
Medical Gloves) | To determine the
amount of residual
and non-powder
solids found on
gloves | Less than 2 mg per glove
Requirement: