(207 days)
Not Found
No
The device description and intended use are for standard examination gloves, and there is no mention of AI or ML in the provided text.
No
The device is a patient examination glove, intended to prevent contamination, not to treat a condition or disease.
No
Explanation: The device is described as a "powder free patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." Its purpose is contamination prevention, not diagnosis.
No
The device description clearly states it is a physical product (gloves) and the performance studies focus on physical and biological properties, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical characteristics of a glove (material, texture, color, size, etc.). It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Detecting specific analytes (e.g., glucose, antibodies, DNA).
- Providing diagnostic information about a patient's health status.
- Using reagents or other substances to perform a test.
The tests performed (physical properties, watertightness, powder content, biocompatibility) are standard for medical gloves to ensure their safety and effectiveness as a barrier, not for diagnostic performance.
Therefore, based on the provided information, this device is a medical glove intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A powder free 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. The device is for over-the-counter use.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The proposed Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, Not made with natural rubber latex and is made of nitrile (Butyronitrile latex) . It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile. The device is provided in 4 sizes, from small to extra-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 / Not Found
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.
Key results include:
- Physical Dimensions Test (ASTM D6319-19): Passed for length, width, and thickness across sizes S, M, L, XL.
- Physical properties (ASTM D6319-19): Passed for Tensile Strength (Before and After Aging) and Ultimate Elongation (Before and After Aging).
- Watertightness Test for Detection of Holes (ASTM D5151-19): Passed (0/200).
- Powder Content (ASTM D6124-06/(R)2017): Passed (0.1mg).
- Irritation (ISO 10993-10: 2010): Passed, non-irritant.
- Sensitization (ISO 10993-10): Passed, non-sensitizing.
- Systemic Toxicity (ISO 10993-11): Passed, no evidence of systemic toxicity from the extract.
- Cytotoxicity (ISO 10993-5): Passed, though the extract showed potential toxicity to L-929 in the MTT method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Physical Dimensions (Length, Width, Thickness)
- Tensile Strength (MPa)
- Ultimate Elongation (%)
- Freedom from Holes (AQL 2.5)
- Residual Power (mg/pc)
- Irritation (non-irritating)
- Sensitization (non-sensitizing)
- Acute Systemic Cytotoxicity (no mortality or evidence of systemic toxicity)
- In Vitro Cytotoxicity (Viab.% of 100% test article extract is 9.87%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 9, 2022
Watchtower PPE Supplies Inc. % Rafi Wong Manager Pacific Fortune Management Inc. 2350 Mission College Blvd. Ste 475 Santa Clara, California 95054
Re: K212929
Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 15, 2022 Received: March 16, 2022
Dear Rafi Wong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Nitrile Examination Gloves
Indications for Use (Describe)
A powder free 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. 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510K SUMMARY K212929
Date of Summary Prepared: March 15, 2022
510K Number: K212929
1. Submitter Information
Submitter Contact:
Address:
WATCHTOWER PPE SUPPLIES, INC. 600 W John Street, Ste 140B, Hicksville, New York 11801, USA
Submitter Contact Person:
| Name: | Riva Zheng |
|---|---|
| Phone Number: | (+1)646-717-6266 |
| Email: | watchtowersupplies@gmail.com |
| Designated Submission Correspondent: | ||
|---|---|---|
| Name: | Rafi Wong |
|---|---|
| Phone Number: | +1 (408) 646-6537 |
| Email: | rafi.wong@pfmfinance.com |
-
- Device Name: Nitrile Examination Gloves
3. Regulatory Information
| Common Name: | Polymer Patient Examination Glove |
|---|---|
| Apparel Classification: | Class I |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |
4
4. Predicate Device
| 510K Number: | K192333 |
|---|---|
| Company name: | JR Engineering & Medical Technologies (M) SDN.BHD. |
| Device Name: | Blue Nitrile Examination Gloves Powder Free |
| Cleared date: | January 24, 2020 |
5. Intended Use/Indications for Use
A powder free 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. The device is for over-the-counter use.
Device Description 6.
The proposed Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, Not made with natural rubber latex and is made of nitrile (Butyronitrile latex) . It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile. The device is provided in 4 sizes, from small to extra-large.
7. Summary of Comparison and Technological Characteristics
| Characteristics | Acceptance
Criteria | Proposed Device
Nitrile
Examination
Gloves | Predicate Device
Blue Nitrile
Examination
Gloves Powder
Free | Comparison |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510K Number | / | K212929 | K192333 | - |
| Product Code | LZA | LZA | LZA | Same |
| Manufacturer | / | WATCHTOWER
PPE SUPPLIES,
INC. | JR Engineering &
Medical
Technologies (M)
SDN.BHD. | Different |
| Classification | Class I (21 CFR
880.6250) | Class I (21 CFR
880.6250) | Class I (21 CFR
880.6250) | Same |
| | | | | |
| Intended Use /
Indications for Use | A patient
examination
glove is a
disposable
device intended
for medical
purposes that is
worn on the
examiner's hands
or fingers to
prevent
contamination
between patient
and examiner.
The device is for
over- the-counter
use. | A powder free
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.
The device is for
over-the-counter
use. | A powder free
patient examination
gloves 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. | Same |
| Material Use | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Dimensions
(ASTM
D6319- 19) | Overall
Length
(mm) 220
mm = (sizes
XS-S)
230 mm =
(sizes M-
XL)
Width (±10
mm) Size S =
80 mm Size
M = 95 mm
Size L = 110
mm Size XL
= 120 mm
Thickness at
Finger
(mm)
All Sizes =
0.05mm
Thickness at
Palm
(mm) | Size: M
Length Min:
230mm Palm
Width Min: 95
+/-10mm
Finger
Thickness min:
0.05 mm Palm
Thickness
min: 0.05 mm | Size: M
Length
Min:
230mm
Palm Width Min:
95+/-10mm
Finger Thickness
min: 0.05 mm
Palm Thickness
min: 0.05 mm | Same |
| | All Sizes =
0.05mm | | | |
| | Before Aging ASTM D6319-19 | | | |
| Physical
Properties | Tensile
Strength
(MPa) = 14
min. | Tensile Strength
(Mpa)
$≥$ 14 min. | Tensile Strength
(Mpa) = 14 min. | Same |
| | Ultimate
Elongation
(%) = 500
min. | Ultimate
Elongation
(%) 500 min. | Ultimate
Elongation (%)
= 500 min. | Same |
| | After Aging ASTM D6319-19 | | | |
| | Tensile
Strength
(Mpa) = 14
min. | Tensile Strength
(Mpa)
$≥$ 14 min. | Tensile
Strength (Mpa)
$≥$ 14 min. | Same |
| | Ultimate
Elongation
(%) = 400
min. | Ultimate
Elongation
(%) 400 min. | Ultimate
Elongation
(%) 400 min. | Same |
| Freedom from
Holes
(ASTM D5151) | AQL 2.5
Inspection
Level G-1 | Passes AQL-2.5 | Passes AQL-2.5 | Same |
| Residual
Power (ASTM
D6124) | $≤$ 2.0 mg/pc | $≤$ 2.0 mg/pc | $≤$ 2.0 mg/pc | Same |
| | Primary Skin
Irritation Test
ISO 10993-
10 | Under the
conditions of
study, the test
article showed no
irritation
on the skin. | Under the condition
of study not an
irritant. | Same |
| Biocompatibility | Dermal
Sensitization
Assay
ISO 10993-
10 | Under the
conditions of
study, there is no
evidence that the
test article
extracts would
cause
sensitization on
guinea pig. | Under the
conditions of the
study not a
sensitizer. | Same |
| | In Vitro
Cytotoxicity
ISO 10993-5 | Under the
conditions of this
study,the MEM
test extracts
would be
considered
cytotoxic
potential. | Under the
conditions of the
study, cytotoxic.
Additional testing
was performed to
determine if this
was a systemic
toxicity concern. | Same |
| | Acute
Systemic
Cytotoxicity
ISO
10993-11 | Under the
conditions of this
study, there is no
mortality or
evidence of
systemic toxicity
from the extracts.
The test met the
test requirements. | Under the condition
of the study the
device extracts do
not pose a systemic
toxicity concern. | Same |
| | Material
Mediated
Pyrogenicity
ISO 10993-
11 | Under the
conditions of this
study, the test
article would be
considered no
febrile reaction.
The test article
meets the test
requirements. | Not performed | N/A |
Table I - General Comparison
5
6
7
8
8. Non-clinical Tests Performed on the Proposed Device
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual Document, issued on January 22, 2008
STANDARDS:
- 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/(R)2017 Standard Test Method for Residual Powder on Medical Gloves
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices – Part 10: Tests For Irritation And Skin Sensitization
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices – Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993- 1: 2009/(R)2013 Biological Evaluation of Medical Devices- Part 1: Evaluation . and testing within a risk management process
- . ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
- . ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
9
| Test Method | Purpose | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| ASTM D6319-19 | Physical | ||||
| Dimensions | |||||
| Test | Length(mm): | ||||
| S:≥220; | |||||
| M/L/XL:≥230; | |||||
| Width(mm): | |||||
| S: 80±10; | |||||
| M: 95±10; | |||||
| L: 110±10; | |||||
| XL: 120±10 | |||||
| Thickness (mm): | |||||
| Finger: ≥0.05 | |||||
| Palm: ≥0.05 | Length(mm): >240/Pass; | ||||
| Width(mm): | |||||
| S: 87-88/Pass | |||||
| M: 96-97/ Pass | |||||
| L: 110/ Pass; | |||||
| XL:114-115/ Pass | |||||
| Thickness (mm): | |||||
| S: | |||||
| Finger: 0.115-0.123/Pass | |||||
| Palm: 0.066-0.073/Pass | |||||
| M: | |||||
| Finger: 0.120-0.132/Pass | |||||
| Palm: 0.067-0.075/Pass | |||||
| L: | |||||
| Finger: 0.118-0.125/Pass | |||||
| Palm: 0.069-0.073/Pass | |||||
| XL: | |||||
| Finger: 0.113-0.120/Pass | |||||
| Palm: 0.068-0.072/Pass | |||||
| Physical properties | Before | ||||
| Aging | Tensile | ||||
| Strength | ≥14MPa | 30.7-38 MPa/Pass | |||
| Before | |||||
| Aging | Ultimate | ||||
| Elongation | ≥500% | 500-525%/Pass | |||
| After | |||||
| Aging | Tensile | ||||
| Strength | ≥14MPa | 22.4-41 MPa/Pass | |||
| After | |||||
| Aging | Ultimate | ||||
| Elongation | ≥400% | 457-516%/Pass |
Table II. Summary of Non-Clinical Performance Testing
10
| ASTM D5151-19 | Watertightness
Test for Detection
of Holes | Meet the requirements of
ASTM D5151
AQL 2.5 | 0/200/Pass |
|---------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D6124-
06/(R)2017 | Powder Content | Meet the requirements of
ASTM D6124