(35 days)
Not Found
No
The 510(k) summary describes a standard medical glove and contains no mention of AI or ML technology.
No
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to treat or cure a disease or condition.
No.
The device is a patient examination glove, which is used to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device is a physical product (gloves) and the summary describes physical performance testing, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description confirms it's a glove for examination purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
This powdered Nitrile exam glove is intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The device is powdered Nitrile Exam Gloves. They are non-sterile, single use, disposable gloves.
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
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)
The device has met and/or exceeded the requirements of the following standards and laboratory tests:
ASTM D3578-95
Primary Skin Irritation Study
Dermal Sensitization Study
FDA Water Leak, before & after aging at AQL 1.5
All tests were performed in a certified testing laboratory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the number '9', another '9', the number '1', the number '8', the number '2', and ends with the number '1'. The characters are written in a simple, slightly uneven style.
- 1 1999 JUL
27 JANNA TUCKER & ASSOCIATES
| 198 Avenue De La D'emerald | |||
|---|---|---|---|
| 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | Sparks, NV 89434-9550 | ||
| Ph: 775-342-2612 | |||
| Fax: 775-342-2613 | |||
| NINGBO YUJIANG PLASTIC & RUBBER CO., LTD | |||
| NITRILE EXAMINATION GLOVE, POWDERED | |||
| Submitter: | Janna Tucker & Associates | ||
| 198 Avenue de la D'emerald | |||
| Sparks, NV 89434 | |||
| PHONE: | |||
| FAX: | (775) 342-2612 | ||
| (775) 342-2613 | |||
| Contact Person: | Janna P. Tucker, President, Janna Tucker & Associates | ||
| Date Prepared: | May 26, 1999 | ||
| Trade Name: | |||
| Common Name: | |||
| Classification Name: | (Multiple) Nitrile Examination Glove, Powdered | ||
| Nitrile Exam Glove, Powdered | |||
| Nitrile Examination Glove, Class I, 80LZA | |||
| Summary of Safety | |||
| and Effectiveness: | Information supporting claims of substantial equivalence, as | ||
| defined under the Federal Food, Drug and Cosmetic Act, | |||
| respecting safety and effectiveness is summarized below. For | |||
| the convenience of the Reviewer, this summary is formatted in | |||
| accordance with the Agency's final rule "... (510(k) Summaries | |||
| and 510(k) Statements..." (21 CFR 807) and can be used to | |||
| provide a substantial equivalence summary to anyone requesting | |||
| it from the preparer. | |||
| NEW DEVICE NAME: | NITRILE EXAMINATION GLOVE, | ||
| POWDERED | |||
| PREDICATE DEVICE NAME: | Nitrile Exam Glove, Powder-Free | ||
| K980677, everything is the | |||
| same process except for adding | |||
| powder to finished glove. | |||
| Device Description: | The device is powdered Nitrile Exam Gloves. They are non- | ||
| sterile, single use, disposable gloves. | |||
| Intended Use: | This powdered Nitrile exam glove is intended for medical | ||
| purposes that is worn on the examiner's hand or finger to prevent | |||
| contamination between patient and examiner. |
EXHIBIT L
Page 28 of 29
1
| Indications Statement: | 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. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | This Nitrile exam glove has the same technological
characteristics as predicate devices. The device is manufactured in
standard sizes. |
| Performance Data: | The device has met and/or exceeded the requirements of the
following standards and laboratory tests: |
| | ASTM D3578-95
Primary Skin Irritation Study
Dermal Sensitization Study
FDA Water Leak, before & after aging at AQL 1.5
All tests were performed in a certified testing laboratory. |
| Conclusions: | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
device is substantially equivalent to other like devices under the
Federal Food, Drug, and Cosmetic Act. The predicate device
is the powder-free Nitrile Exam Glove, same manufacturer,
(K.980677), except this new glove is powdered. |
JANNA P. TUCKER, President Janna Tucker & Associates Official Correspondent for Ningbo Yujiang Plastic & Rubber Co., Ltd.
EXHIBIT L
Page 29 of 29
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Ningbo Yujiang Plastic & Rubber Company c/o Ms. Janna P. Tucker Official Correspondent Janna Tucker & Associates 198 De La D'emerald Sparks, Nevada 89434-9550
Re: K991821 Nitrile Examination Glove, Powdered, Blue Trade Name: Requlatory Class: I Product Code: LZA Dated: May 26, 1999 Received: May 27, 1999
Dear Ms. Tucker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Tucker
this response to your premarket notification Please note: submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Runo
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
APPLICANT:
NINGBO YUJIANG PLASTIC & RUBBER CO., LTD
510(K) NUMBER:
Kg91821
DEVICE NAME:
Blue Nitrile Examination Glove, Powdered
A patient examination glove is a disposable device intended for medical purposes that is A patient examiner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
EXHIBIT B
Page 2 of 2
Olin S. Lin
(Division Sign-Off)
Bigh-off)
Division of Dental, Infection Control,
eneral Hospital Devices
her