(62 days)
A finger cot is a disposable device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner.
Latex Finger Cot, Powder-Free, with Protein Labeling
This 510(k) submission (K980827) describes a Latex Finger Cot, Powder-Free, with Protein Content Labeling Claim (50 Micrograms or Less). This device is a Class I medical device (Product Code: LZB) and is substantially equivalent to predicate devices already on the market.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not include specific quantitative acceptance criteria or detailed device performance results beyond the protein labeling claim. The submission focuses on substantial equivalence to existing devices.
| Acceptance Criteria (Inferred from labeling claim) | Reported Device Performance (As stated in the device name) |
|---|---|
| Latex protein level (as indicated by the claim) | Protein Labeling Claim (50 Micrograms or Less) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary and FDA letter do not describe a specific clinical or performance study with a test set. The submission relies on demonstrating substantial equivalence to predicate devices already on the market. Therefore, information on sample size and data provenance for a test set is not applicable here as no such study is detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no specific study with a test set is detailed in the provided documents, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
As no specific study with a test set is detailed, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is described in the provided documents. The submission focuses on substantial equivalence of the device itself, not on its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical device (latex finger cot), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used
Given that this is a physical device and the submission focuses on substantial equivalence based on its physical characteristics and intended use, the "ground truth" would primarily refer to objective measurements of the device's properties (e.g., latex protein content, physical integrity, barrier properties) and comparison to established standards for similar devices. However, the provided documents do not detail these specific measurements or the type of ground truth used beyond the protein claim.
8. The Sample Size for the Training Set
No training set is mentioned or applicable as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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K980827
4 1998 MAY
510(k) SUMMAR Y
| Submitted By: | Janna Tucker & Associates19001 S. Richfield #185Green Valley, AZ 85614Phone: 520-625-2904FAX: 520-625-3908 | ||
|---|---|---|---|
| Contact Person: | Janna P. Tucker, Official Correspondent forSinochem Ningbo Latex Gloves Factory | ||
| Date of Submission: | 2 March 1998 | ||
| Device Name: | Latex Finger Cot, Powder-Free, with Protein Labeling | ||
| Proprietary Name: | (Multiple Labels) Latex Finger Cot, Powder-Free, withProtein Labeling | ||
| Labels/Labeling: | This device will be marketed to healthcare professionals at dentist,and doctor offices, laboratories, clinics and hospitals through itsintended use. | ||
| Intended Use: | A finger cot is a disposable device intended formedical purposes that is worn on the examiner's fingerto prevent contamination between patient and examiner. | ||
| Substantial Equivalence: | This device is equivalent to those in commercial distribution. Theyare to be worn as a protective device on the examiner's finger. |
Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies.
EXHIBIT L
Page 39 of 40
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a caduceus, which is a symbol of medicine and health. The caduceus is made up of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 MAY
Sinochem Ningbo Latex Gloves Factory C/O Ms. Janna P. Tucker Official Correspondent for Sinochem Ningbo Latex Gloves Factory Ms. Janna Tucker & Associates 19001 South Richfield #185 Green Valley, Arizona 85614
K980827 Re : Latex Finger Cot, Powder-Free, with Protein Trade Name: Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LZB March 2, 1998 Dated: March 3, 1998 Received:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against 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 -----regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Ms. Tucker
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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) 638-20A1 or (301) 443-6597 or at its internet address "http://www.fdajgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy R. Ulatowski
Tim Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
:
.' '. Sinochem Ningbo Latex Gloves Factory APPLICANT: 980827 510(K) NUMBER : LATEX FINGER COT, POWDER-FREE, WITH PROTECTION CONTENT DEVICE NAME: LABELING CLAIM ( 50 MACROGRAMS OR LESS)
A patient examination glove is a disposable device intended for medical purposes that is
t and A patient examination glove is a disposable device incomination 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)
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
|---|---|
| 510(k) Number | K980827 |
| Prescription Use_ | OR | Over-The-Counter Use_X |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
EXHIBIT B
Page 2 of 40
§ 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.