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# FDA Denies Nautilus Glove Reconsideration Request
- URL: https://www.fdaweb.com/fda-denies-nautilus-glove-reconsideration-request/
- Published: 2024-06-05T12:00:00.000Z
- Updated: 2026-09-14T14:32:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157114

FDA has denied a Nautilus Glove 1/11 request for reconsideration and petition for stay of action that asked the agency to **(1)** reconsider its recission of 510(k) substantial equivalence for the Nautilus Nitrile Exam Gloves and permit the company to amend its 510(k) with the correct *in vitro* cytotoxicity data, and **(2)** stay the recission pending its reconsideration by the commissioner. The denial [letter](https://downloads.regulations.gov/FDA-2024-P-0279-0007/attachment%5F1.pdf?ref=fdaweb.com) says the case involves a CDRH 6/9/2023 notification that it is appropriate to rescind the 510(k) clearance due to misconduct involved in submitting biocompatibility data that appeared to be duplicated as it was identical to data from an unrelated submission. The notice said that had FDA known the data were invalid and duplicated at the time the submission was reviewed, it would have rendered a not substantially equivalent determination.

FDA says it disagrees with the company’s assertion that the agency lacks authority to rescind a 510(k) clearance and disagrees that there is no evidence of misconduct. While the company assigns the submission of inappropriate data to a “clerical error,” the letter says, “there appears to have been misconduct by one or more entities that led to the submission of the invalid information.” It lists several indications of misconduct that it has seen.

Because the data in the 510(k) submission are invalid, FDA says, the submission clearance must be rescinded and cannot be opened to amendment as Nautilus requested. The letter says Nautilus can file a new 510(k) submission for the gloves with the appropriate data and it would be reviewed by the agency.

The letter says the request to say the rescission while it is considered by the commissioner is denied since regulations cite four reasons for granting such a petition and Nautilus has not given information to justify its request in terms of the four conditions.